Aerobiotix™ Expands Senior Management Team and Enters New Market Segments

Posted On September 20, 2016 By OrthoSpineNews In Top Stories /

September 20, 2016

LAS VEGAS–(BUSINESS WIRE)–Aerobiotix, Inc., an emerging leader in the development of novel technologies for indoor air quality (IAQ), announces the appointment of Daniel Abromowitz as VP of Sales and Marketing. Mr. Abromowitz is an established leader in building sales and marketing infrastructure in the medical device and pharmaceutical industries. Most recently, he was VP of Sales for Xtant Medical (NYSE: XTNT), and prior to that he was VP of Sales for X-spine Systems, Inc. Mr. Abromowitz is tasked with building penetration in targeted segments of healthcare, home care, and HVAC markets.

Aerobiotix™ is embarking on an aggressive product expansion plan to introduce five new product offerings within the next twelve months to address critical needs in healthcare and whole-home IAQ markets. Aerobiotix™ recently expanded its home care line of products with the launch of the AeroCure™ DNA Dust and Allergy air purifier. Designed to fight home or office dust and allergens, these units continue Aerobiotix’s standard of high-end IAQ products manufactured in the USA. This product joins the AeroCure™ by Aerobiotix™ line of high-end home air purification systems, and the Tower One line of healthcare air disinfection systems used in leading hospitals.

Privately-held Aerobiotix, Inc. is dedicated to developing, manufacturing and marketing global solutions for air quality in healthcare, home care, and HVAC markets. Aerobiotix will be showcasing its technologies at the upcoming industry tradeshows: Operating Room Manager Conference in Las Vegas, NV, September 21-23, 2016 at booth 1033 and Association for the Healthcare Environment Conference in Pittsburgh, PA, September 25-28, 2016 at booth 733.

Contacts

Aerobiotix, Inc.
Daniel Abromowitz, 937-422-8405
VP of Sales and Marketing
dabromowitz@aerobiotix.com

Graphene nanoribbons show promise for healing spinal injuries

Posted On September 20, 2016 By OrthoSpineNews In Biologics, Neuro /

September 20, 2016 – Rice University

The Tour lab has spent a decade working with graphene nanoribbons, starting with the discovery of a chemical process to “unzip” them from multiwalled carbon nanotubes, as revealed in a Nature paper in 2009. Since then, the researchers have used them to enhance materials for the likes of deicers for airplane wings, better batteries and less-permeable containers for natural gas storage.

Now their work to develop nanoribbons for medical applications has resulted in a material dubbed Texas-PEG that may help knit damaged or even severed spinal cords.

A paper on the results of preliminary animal-model tests appears in the journal Surgical Neurology International.

Graphene nanoribbons customized for medical use by William Sikkema, a Rice graduate student and co-lead author of the paper, are highly soluble in polyethylene glycol (PEG), a biocompatible polymer gel used in surgeries, pharmaceutical products and in other biological applications. When the biocompatible nanoribbons have their edges functionalized with PEG chains and are then further mixed with PEG, they form an electrically active network that helps the severed ends of a spinal cord reconnect.

“Neurons grow nicely on graphene because it’s a conductive surface and it stimulates neuronal growth,” Tour said.

In experiments at Rice and elsewhere, neurons have been observed growing along graphene.

“We’re not the only lab that has demonstrated neurons growing on graphene in a petri dish,” he said. “The difference is other labs are commonly experimenting with water-soluble graphene oxide, which is far less conductive than graphene, or nonribbonized structures of graphene.

“We’ve developed a way to add water-solubilizing polymer chains to the edges of our nanoribbons that preserves their conductivity while rendering them soluble, and we’re just now starting to see the potential for this in biomedical applications,” he said. He added that ribbonized graphene structures allow for much smaller amounts to be used while preserving a conductive pathway that bridges the damaged spinal cords. Tour said only 1 percent of Texas-PEG consists of nanoribbons, but that’s enough to form a conductive scaffold through which the spinal cord can reconnect.

Texas-PEG succeeded in restoring function in a rodent with a severed spinal cord in a procedure performed at Konkuk University in South Korea by co-authors Bae Hwan Lee and C-Yoon Kim. Tour said the material reliably allowed motor and sensory neuronal signals to cross the gap 24 hours after complete transection of the spinal cord and almost perfect motor control recovery after two weeks.

“This is a major advance over previous work with PEG alone, which gave no recovery of sensory neuronal signals over the same period of time and only 10 percent motor control over four weeks,” Tour said.

The project began when Sikkema read about work by Italian neurosurgeon Sergio Canavero. Sikkema thought nanoribbons might enhance research that depended on PEG’s ability to promote the fusion of cell membranes by adding electrical conductivity and directional control for neurons as they spanned the gap between sections of the spinal cord. Contact with the doctor led to a collaboration with the South Korean researchers.

Tour said Texas-PEG’s potential to help patients with spinal cord injuries is too promising to be minimized. “Our goal is to develop this as a way to address spinal cord injury. We think we’re on the right path,” he said.

“This is an exciting neurophysiological analysis following complete severance of a spinal cord,” Tour said. “It is not a behavioral or locomotive study of the subsequent repair. The tangential singular locomotive analysis here is an intriguing marker, but it is not in a statistically significant set of animals. The next phases of the study will highlight the locomotive and behavioral skills with statistical relevance to assess whether these qualities follow the favorable neurophysiology that we recorded here.”

Story Source:

The above post is reprinted from materials provided by Rice University. Note: Content may be edited for style and length.

Journal Reference:

JamesM Tour, BaeHwan Lee, C-Yoon Kim, WilliamK. A. Sikkema, In-Kyu Hwang, Hanseul Oh, UnJeng Kim. Spinal cord fusion with PEG-GNRs (TexasPEG): Neurophysiological recovery in 24 hours in rats. Surgical Neurology International, 2016; 7 (25): 632 DOI:10.4103/2152-7806.190475

VEXIM: Strong First Half 2016 Results in Line with Expectations

Posted On September 20, 2016 By OrthoSpineNews In Financial /

September 20, 2016 – TOULOUSE, France–(BUSINESS WIRE)

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, announces its consolidated results for the first half of 2016¹ in line with guidance.

“Sales increased sharply throughout the first half of 2016, a continued trend that should be reinforced in the second half of 2016. Therefore, we are confident we should reach our profitability target in 2016. In addition, the clinical study we launched in June 2015, with the aim of receiving the 510(k) clearance required to market the SpineJack® in the United States, continues on plan. These various accomplishments indicate that our company is well positioned to become a global leader in the spine-trauma market”, comments Vincent Gardès, VEXIM’s CEO.

+40% increase in sales, gross margin up 45% and significant loss reduction

VEXIM’s sales reached €8.6 million in the first half of 2016, up 40% compared to the same period in 2015. This significant revenue growth shows the effectiveness of the direct sales strategy implemented for the SpineJack® in Europe, combined with a network of specialized distributors at the international level (see press release on VEXIM’s sales in the first half of 2016²).

The gross margin on sales increased by 45% compared to the first half of 2015, up to €6.4 million, representing 74.2% of sales vs. 71.9%. This resulted from rising sales in Europe in a context of stable prices as well as from the direct sales strategy implemented.

Compared to the 40% increase in revenue, operating expenses only increased by 12%, up to €8.7 million, compared with the first half of 2015. Such effective control over operating expenses resulted in a saving of €1 million in the net operating loss, down to €2.4 million. Net loss for the period was €2.5 million.

Consolidated statement as of June 30, 2016:
in € millions	First Half 2016	First Half 2015	YoY (%)
Sales	8.565	6.111	+40%
Gross margin (% of sales)	6.359 (74.2%)	4.392 (71.9%)	+45%
Operating expenses	8.722	7.802	+12%
Net operating income (loss)	-2.363	-3.410	+30%
Net income (loss)	-2.529	-3.647	+30%

Solid cash position at €9.4 million

In January 2016, VEXIM reinforced its cash position thanks to a successful €10.4 million private placement. As of June 30, 2016,VEXIM had €9.4 million in cash, allowing the company to secure its future development. The company’s current cash position and future cash flows should allow VEXIM to continue to grow in line with its ambitions.

Other business achievements over the first half of 2016

Launch of a medico-economic study comparing the SpineJack® to a conventional treatment (bracing) with a 1- and 2-year follow-up.
Strengthening of the executive team, with the addition of Francois Cathelineau as VP Operations and of Sebastien Lemoine as VP International & Marketing.

Full-year 2016 guidance confirmed

Thanks to its solid results in the first half of 2016, VEXIM is in running order to reach its full-year 2016 objectives:

Maintain strong revenue growth between 30% to 40% over the full year 2016;
Achieve profitability for the full second half of 2016 and generate operational positive cash-flows;
Further expand internationally through upcoming distribution agreements in South Africa and Australia in 2016, and in Brazil and South Korea in 2017;
Continue the enrollment of patients for the FDA clinical study of the SpineJack® and continue looking for the adequate distribution model for the SpineJack® in the U.S.
Keep innovating in the treatment of high energy vertebral fractures through product development projects, leveraging the SpineJack® platform.

Conference call – 2016 first-half results presentation (in English)
Tuesday 20 September 2016, at 6:30 PM (Paris time)

To join the call please contact ALIZE RP
By telephone at: +33 (0)1 44 54 36 62 – By email at:

vexim@alizerp.com

A replay of the conference call will be available on VEXIM’s website within 48 hours at:
http://www.vexim.com/us/ (US section of the website) > Shareholder area

***

Financial reporting schedule:
3^rdquarter sales results: Thursday, October 13, 2016* (after market close)
*indicative date, subject to change

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital³ and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 62 employees, including its own sales teams in Europe and a network of international distributors.
VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® ⁴, a revolutionary implant for treating Vertebral Fractures
The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

Masterflow^TM ², a high-performance orthopedic cement delivery system
The Masterflow^TM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the Masterflow^TM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The Masterflow^TM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

Name : VEXIM
ISIN code : FR0011072602
Ticker : ALVXM

¹ The results, which were subject to a limited review, have been approved by the Board of Directors of Vexim at its meeting held on 14 September 2016.
² Press release published on July 12, 2016: http://www.vexim.com/us/vexim-40-revenue-growth-in-the-1st-half-2016-upper-range-of-goals/
³ Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
⁴ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès
CEO
or
José Da Gloria
Chief Financial Officer
Tél. : +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

3D Printing Helps Surgeon Restore Child’s Sporting Ambitions and Reduce Surgery Time from 4 hours to Under 30 minutes

Posted On September 20, 2016 By OrthoSpineNews In Extremities /

BELFAST (PRWEB UK) 13 SEPTEMBER 2016

When anxious parents approached Mr Michael Eames, Consultant Orthopaedic Surgeon at the South Eastern Trust, to investigate and help correct their young son’s injured forearm, little did they know that 3D printing would so drastically change the course of their son’s treatment.

Having suffered a complex forearm injury as a toddler a number of years earlier, the young patient’s bones had healed in an abnormal position preventing him from rotating his arm. This restriction of movement in a young child can be very detrimental to his development, sporting ambitions and career aspirations.

According to Michael Eames, the patient’s CT scan confirmed that the bones had, as suspected, healed incorrectly leading the team down the standard line of treatment of trying to reshape the bones to gain normal rotation. However, having access to a full-scale 3D printed model of the patient’s bones changed everything.

The South Eastern Trust supplied the patient’s CT scan data to Belfast-based medical 3D printing firm, Axial3D that produces bespoke hard and soft tissue models from 2D patient scan data for public and private healthcare across a wide variety of specialisms including orthopaedics, oncology, maxillofacial, cardiac and trauma.

Michael Eames said that the 3D printed model of his patient’s forearm bones offered unprecedented insight for diagnosing his patient and ultimately changed the course of his treatment, “We approached Axial3D to have the bones printed and that was enlightening. It showed us that while the shape of the bones was grossly abnormal, it wasn’t the shape of the bones that was limiting the rotation. It was the tight structures between the bones that had scarred down that was preventing the child from rotating his arm. Having a tangible scale piece of anatomy provides huge insight into the pathology not possible on conventional CT or MRI scans.”

Access to a bespoke 3D printed model of the patient’s forearm bones changed the standard course of treatment from a 4 hour complex surgery to reshape the bones and the ensuing rehabilitation, to a much less evasive soft tissue procedure that took just under 30 minutes.

According to Daniel Crawford, Axial3D CEO, their bespoke models offer clinicians a deeper appreciation of their patient’s ailment or injury beyond what is possible with conventional 2D imaging: “Axial3D’s patient-specific anatomical models give clinicians greater insight and therefore confidence in diagnosing and treating complex cases. In some cases, our models have been used to develop and trial novel surgical techniques pushing the boundaries of surgical intervention. The adoption of 3D medical printing has the potential to revolutionise medical provision.”

To fulfil its mission to provide easy access to patient-specific tools, Axial3D recently launched an online service for clinicians to upload patient CT and MRI scans, visualise them in 3D and order precise 3D printed models in minutes. For this young patient, access to the model provided a more accurate diagnosis, less evasive procedure, faster recovery and, four weeks post op, he was discharged with 90% range of movement in his forearm and no pain.

This week Axial3D is showcasing its bespoke 3D printed orthopaedic models at the British Orthopaedic Association Congress [13-16 September at the Waterfront Hall, Belfast], an annual event that is expected to attract over 1,000 orthopaedic surgeons to the city.

Tether-Clamp-and-Implantation-System-Band-Lok-Patent-1.png

Band-LOK, LLC Announces the First Surgery of its Pedicle-Sparing Polyester Band Spinal Technology.

Posted On September 20, 2016 By OrthoSpineNews In Spine /

WAXHAW, NC (PRWEB) SEPTEMBER 20, 2016

Band-LOK, LLC a developer of anatomy friendly medical technologies for orthopedics, today announced the first-of-its-kind spinal surgery using the company’s pedicle-sparing polyester band technology; made available to the market via a licensing agreement with OrthoPediatrics Corp (Warsaw, IN).

“The Band-LOK technology was developed as a novel way to approach various orthopedic defects using polyester bands and intuitive instrumentation. The Band-LOK system changes the paradigm for treating bone pathologies, including complex spinal deformities like scoliosis,” said John Kapitan, head of R&D and Co-Founder of Band-LOK.

Dr. Mike Albert performed the first case on August 22, 2016, at Dayton Children’s Hospital in Dayton, Ohio. “The technology’s unique Tether Clamp System was used in a neuromuscular scoliosis measuring 90 degrees,” said Dr. Albert. “The case went exceptionally well; demonstrating the versatility, simplicity and power of the band to correct severe spinal deformities. The system performed flawlessly, gradually correcting this large spinal deformity with no bone or band failures.”

Band-LOK, LLC was granted a patent by the United States Patent and Trademark Office (USPTO) in November, 2015, and has other patents pending. The company is focused on expanding its band technology to other orthopedic applications and exploring synergistic licensing agreements beyond spine.

Randy Roof, President and Co-Founder added, “We are in the business of pushing boundaries of tether band technology for orthpedics, and the first clinical case is an important step in that direction.”

About Band-LOK, LLC.

Based in Waxhaw, NC, Band-LOK, LLC. is a medical technology incubator composed of industry veterans and scientists focused on developing a suite of less invasive, anatomy friendly band technologies and a robust IP portfolio.

Contact Information
Randy Roof (President/Co-founder)
Phone: 704-839-1916
Email: mrnuspine(at)me.com

Zimmer Biomet Launches VANGUARD® Individualized Design Knee Replacement

Posted On September 20, 2016 By OrthoSpineNews In Recon /

WARSAW, Ind., Sept. 20, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of Vanguard® Individualized Design (ID), a first-of-its-kind total knee arthroplasty (TKA) construct designed to enable a personalized fit while simplifying soft tissue preservation and balance. Traditional total knee implants feature a one-piece bearing constructed of polyethylene which is placed between the metal portions of the implant. Vanguard ID is the only TKA design to incorporate two individual polyethylene bearings with different articulations on the medial and lateral sides. The Vanguard ID’s flexible design allows surgeons to mix and match bearings of differing thickness and geometry, ensuring they can personalize their approach to accommodate and preserve natural soft tissue.

“I believe that our newly released Vanguard Individualized Design will revolutionize total knee replacement. With the ability to fine tune the knee’s balance through the use of independent medial and lateral bearing thickness and constraint options, we will arm the surgeon with the ultimate soft tissue respecting capability,” said Todd Davis, Vice President & General Manager of the global Knee business.

The original Vanguard^® Knee system, which debuted in 2003, pioneered personalization in knee replacement by offering the broadest range of available sizes. By equipping surgeons to combine a vast number of bearings of varying thickness (up to 2 mm) and articulations to ensure a personalized feel, the Vanguard ID builds on the Vanguard knee’s legacy of enabling surgeons to create a personalized fit, while maintaining surgical simplicity and intraoperative flexibility.

“Maintaining natural ligament tension while preserving healthy soft tissue is critical not only to restore normal range of motion but to achieve patient satisfaction,” said Tom Aleto, M.D. (Missouri Orthopedic Institute, Columbia, Missouri). “In traditional knee design, surgeons typically release healthy soft tissues in an attempt to balance the knee and maintain feasible kinematics. Because the Vanguard ID allows me to mix and match components, I am able to individually treat each compartment while maintaining healthy soft tissues. I personally feel that, by utilizing Vanguard ID and a soft tissue respecting surgical technique, I’m achieving higher patient satisfaction.”

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

Life Spine Announces FDA Clearance of PRO-LINK® Ti Stand-Alone Cervical Spacer System

Posted On September 20, 2016 By OrthoSpineNews In Spine /

September 20, 2016

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the PRO-LINK Ti Stand-Alone Cervical Spacer System.

“PRO-LINK Ti offers a low-profile, stand-alone cervical interbody with our groundbreaking Osseo-Loc™ technology. Osseo-Loc is a proprietary surface treatment for titanium with 500-600 microns of porosity, which helps create an environment for potential bone growth,” said Rich Mueller, Chief Operating Officer for Life Spine. “Due to the structural integrity of titanium, we were also able to include lateral graft windows for maximum bone graft volume and visibility.”

PRO-LINK® Ti is scheduled for full product release by the end of 2016 and joins Life Spine’s portfolio of twenty products launching in 2016.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
847-884-6117
ofaruqi@lifespine.com

ConvaTec Extends Protection for Surgical Wounds with Launch of AQUACEL® Ag SURGICAL SP Dressing

Posted On September 19, 2016 By OrthoSpineNews In Biologics /

LUXEMBOURG, Sept. 19, 2016 /PRNewswire/ — ConvaTec, a leading global medical technology company, today announced the U.S. launch of AQUACEL^® Ag SURGICAL SP dressing, extending the company’s range of AQUACEL^® Ag SURGICAL cover dressings developed to help reduce surgical site infections.*

AQUACEL^® Ag SURGICAL SP dressing has a thin adhesive layer, to aid conformability for specific types of surgical wounds such as cesarean section and lumbar spine surgery. The new slim profile dressing is also designed to provide the same antimicrobial protection benefits** as AQUACEL^® Ag SURGICAL cover dressings.

Surgical site infections (SSIs) can be devastating to a patient’s health and costly for health care providers. In addition to the burdens of further treatment, under the Affordable Care Act, hospitals in the U.S. with high rates of patient readmissions 30 days post-surgery are subject to reduced reimbursement from Medicare.

“Postoperative wound infection is a leading cause of patient readmission following surgery, and a significant issue for both patients and health care providers,” said Bryan D. Springer, MD, Fellowship Director at OrthoCarolina Hip & Knee Center. “Reducing the risk of SSI is a major focus for our facility. Our experience with AQUACEL^® Ag SURGICAL dressings is that these advanced dressings offer compelling value in terms of patient satisfaction, clinical outcomes and cost.”

“Patients undergoing back, abdominal and other types of surgeries have unique needs to support their post-operative healing and daily activities such as bathing, changing clothes and sleeping,” said Fiona Adam, Vice President and General Manager of Advanced Wound Care. “ConvaTec developed AQUACEL^® Ag SURGICAL SP dressing in response to these specific needs as well as to address the risk of SSIs across a broad range of surgical wounds – in keeping with our commitment to the community of wound care specialists and patients whom we serve and whose lives we touch, every day.”

Published Studies Support Value of AQUACEL^® Ag SURGICAL Dressings

In previous studies, AQUACEL^® Ag SURGICAL cover dressings significantly demonstrated the ability to reduce the incidence of post-operative infection and other complications, such as skin blistering, and improve patient satisfaction.

In a retrospective clinical study of 1,778 patients undergoing hip and knee replacement surgery (total joint arthroplasty or “TJA”), published in The Journal of Arthroplasty, the use of AQUACEL^® Ag Surgical cover dressing vs. standard gauze surgical dressing reduced periprosthetic joint infection (“PJI”) by 76 percent (0.4% vs. 1.7%, p=0.005).

Further results of a randomized controlled trial of 262 TJA patients, published in the American Journal of Orthopedics, found the use of AQUACEL^® Ag SURGICAL cover dressing vs. standard surgical dressing reduced skin blistering by 88 percent (0.7% vs. 6%, p=0.026). The study also found overall patient satisfaction improved 14 percent (mean satisfaction score of 92 vs. 81 out of 100, p=<.0001).

Like AQUACEL^® Ag SURGICAL cover dressing, the new AQUACEL^® Ag SURGICAL SP dressing features Hydrofiber^® Technology, ConvaTec’s proprietary technology designed to help create a beneficial moist wound environment that supports healing. The antimicrobial silver dressing is highly conformable and provides a waterproof viral and bacterial barrier*** that supports patient comfort and hygiene, such as the ability to shower, after surgery.

AQUACEL^® Ag SURGICAL SP received 510(k) clearance from the U.S. Food and Drug Administration earlier this year and is available in a range of sizes to cover a variety of surgical site incisions.

For more information about the AQUACEL^® family of advanced wound dressings and Hydrofiber^® Technology, visitwww.convatec.com or call ConvaTec customer service at 1-800-422-8811.

About ConvaTec
ConvaTec is a global medical products and technologies company focused on therapies for the management of chronic conditions with leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion devices. ConvaTec’s products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. The company is owned by Nordic Capital and Avista Capital Partners.

*Indicated for wounds healing by primary intent. Refer to product Instructions for Use for more information.
**As demonstrated in vitro
**Provided the dressing remains intact and there is no leakage. The use of this dressings neither guarantees nor warranties against AIDS or Hepatitis virus transmission.

– References available on request –

Contact:

Punnie Donohue
ConvaTec
punnie.donohue@convatec.com

SOURCE ConvaTec

Related Links

http://www.convatec.com

NuVasive Receives FDA 510(k) Clearance Reinforcing Comprehensive Portfolio Supporting Pediatric, Adolescent and Adult Spinal Deformity Patients

Posted On September 19, 2016 By OrthoSpineNews In Regulatory /

September 19, 2016

SAN DIEGO, CA–(Marketwired – September 19, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it has received FDA 510(k) clearance for the Company’s market-leading MAGEC® system to be surgically implanted using its Reline® posterior fixation system for treating patients with severe spinal deformity conditions.

The Company’s MAGEC system is the only magnetically controlled growing-rod system cleared by the FDA for pediatric spinal deformity. MAGEC helps surgeons reduce the number of planned surgeries required to effectively treat patients with Early Onset Scoliosis (EOS). Supported by the versatility of the Reline system, NuVasive now offers surgeons a comprehensive solution for treating the most difficult spinal deformities.

“The FDA 510(k) clearance is a key milestone for NuVasive as we continue to deliver new innovation to the spine market, and now more specifically, the pediatric deformity market. More importantly, it reflects an increased ability to better treat children with EOS. Combining the game-changing innovation of MAGEC and the versatility of Reline, we help transform the experience for these young patients. NuVasive is committed to partnering with surgeons to revolutionize deformity surgery for patients in need around the globe,” said Jason Hannon, NuVasive’s president and chief operating officer.

Sonia Garcia, a six-year-old patient suffering from EOS and severe kyphosis, was identified by Shriners International to need urgent spinal deformity correction surgery. Dr. Robert H. Cho, chief of staff and a leading pediatric orthopedic surgeon at Shriners Hospitals for Children — Los Angeles, accepted the case.

“When I first met Sonia, she had a poor chance of surviving past her late teens. Because of her severe scoliosis, her quality of life was declining secondary to her lungs becoming collapsed and constricted by her progressive spinal curvature. Leveraging the versatility and reliability of Reline with the innovative MAGEC rod, we have significantly impacted Sonia’s life and minimized the number of surgeries she will require in the future. Immediately following her surgery, Sonia’s lung capacity increased by more than 30 percent, she reclaimed 10cm of height and her future is bright. This is why I do what I do, to help improve and change lives,” said Dr. Cho.

Sonia’s mother, Sonia Rafaela Garcia Navarro, shared, “I was willing to do whatever it took to find help for my daughter. As a single mother in a remote village in Mexico, we had exhausted our options, and were without hope. However, thanks to Dr. Cho and his clinical staff, Shriners Hospital and NuVasive, I’m speechless. Sonia’s best days are ahead.”

NuVasive’s minimally invasive, procedurally-integrated solutions feature a full portfolio of market-leading spinal deformity technologies, supporting pediatric, adolescent and adult deformities. NuVasive has a rich history of revolutionizing the treatment of adult deformity with the Reline system, Integrated Global Alignment platform (iGA™), Anterior Lumber Interbody Fusion (ALIF) and eXtreme Lateral Interbody Fusion (XLIF®) Anterior Column Realignment™ (ACR) systems. Details of the two technologies from the Company’s comprehensive deformity portfolio that Dr. Cho leveraged to successfully treat Sonia include:

MAGEC is comprised of a single-use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet controlled by an external remote controller. Periodic lengthening of the rod is performed in an office setting where the surgeon externally controls the implant, eliminating the need for a series of distraction surgeries used in the traditional surgical treatment for young patients.

The Reline portfolio reflects an evolution of posterior fixation technology, and is integrated with the iGA platform to treat patients through traditional open or minimally-invasive procedures. Whether preserving or restoring spinal alignment, Reline’s single system addresses the spectrum of spinal pathologies from adult degenerative and deformity to specialized pediatric deformity.

Attendees of the 51^st Annual Scoliosis Research Society annual meeting in Prague, Czech Republic will have the opportunity to learn more about the MAGEC system, as guest speakers David Marks and Dr. Sulken Shah discuss best practices on September 22 at 4:30 p.m. in the Corinthia Hotel Prague.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

About Shriners Hospitals for Children

Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our 22 locations in the United States, Canada and Mexico provide advanced care for children with orthopedic conditions, burns, spinal cord injuries, and cleft lip and palate. Generally, care is provided until age 18, although, in some cases, it may be extended to age 21. All services are provided in a compassionate family-centered environment. For more information, please visit www.shrinershospitalsforchildren.org/losangeles.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

Contact Information

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact

Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact

Don’t Forget the Pulses! Aortoiliac Peripheral Artery Disease Masquerading as Lumbar Radiculopathy—A Report of 3 Cases

Posted On September 19, 2016 By OrthoSpineNews In Neuro, Spine /

Am J Orthop. 2016 July

Lumbar radiculopathy is a common problem encountered by orthopedic surgeons, and typically presents with lower back or buttock pain radiating down the leg.¹ While the most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis, the differential diagnosis for lower extremity pain is broad and can be musculoskeletal, vascular, neurologic, or inflammatory in nature.^1,2Differentiating between orthopedic, neurologic, and vascular causes of leg pain, such as peripheral artery disease (PAD), can sometimes be challenging. This is especially true in aortoiliac PAD, which can present with hip, buttock, and thigh pain. Dorsalis pedis pulses can be palpable due to collateral circulation. A careful history and physical examination is crucial to the correct diagnosis. The history should clearly document the nature of the pain, details of walking impairment, and the alleviating effects of standing still or positional changes. A complete neurovascular examination should include observations regarding the skin, hair, and nails, examination of dorsal pedis, popliteal, and femoral pulses in comparison to the contralateral side, and documentation of dural tension signs. Misdiagnoses can send the patient down a path of unnecessary tests, unindicated procedures, and ultimately, a delay in definitive diagnosis and treatment.¹

To our knowledge, this is the first report on a series of patients with thigh pain initially diagnosed as radiculopathy who underwent unproductive diagnostic tests and procedures, and ultimately were given delayed diagnoses of aortoiliac PAD. The patients provided written informed consent for print and electronic publication of these case reports.

Case 1

An 81-year-old woman with a medical history notable for hypertension, hyperlipidemia, and stroke initially presented to an outside orthopedic institution with complaints of several months of lower back and right hip, thigh, and leg pain when walking. She did not report any history of night pain, weakness, or numbness. Examination at the time was notable for painful back extension, 4/5 hip flexion strength on the right compared to 5/5 on the left, but symmetric reflexes and negative dural tension signs. X-rays showed multilevel degenerative disc disease of the lumbar spine, and magnetic resonance imaging (MRI) showed a small L3/4 disc protrusion causing impingement of the L4 nerve root.

A transforaminal epidural steroid injection at the L4 level was performed with minimal resolution of symptoms. Several months later, right-sided intra-articular facet injections were performed at the L4/5 and L5/S1 levels, again with minimal relief of symptoms. At this point, the patient was sent for further physical therapy.

Over a year after symptom onset, the patient presented to our institution and was evaluated by a vascular surgeon. Physical examination was notable for 1+ femoral artery and dorsal pedis pulses on the right side, compared to 2+ on the left. An aortoiliac duplex ultrasound showed severe significant stenosis of the right common iliac artery (>75%).

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Month: September 2016

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