FDA Extends UDI Compliance for Certain Class II Devices

By Michael Mezher – September 7, 2016

The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices.

In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products.

Under the UDI rule, FDA established a phased, risk-based approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015. Class II devices, other than those listed in Tuesday’s letter, will need to comply later this month.

Since issuing the final rule in 2013, FDA has pushed back UDI compliance dates for certain products, such as Class III contact lenses and number of different orthopedic implants. Last week, FDA announced it would delay enforcement of another UDI provision that would require device makers to remove National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers from their devices by 24 September 2018 by three years.

Class II UDI Compliance

Now, FDA says it is extending the compliance date for certain Class II devices from 24 September 2016 to 24 September 2018, giving manufacturers two more years to meet UDI requirements for the affected products.

 

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Medtronic Recognized as a Sustainability Leader

DUBLIN – September 8, 2016 – Medtronic plc (MDT) was recognized today as one of the world`s leading companies for sustainability with its ranking on the Dow Jones Sustainability North America Index (DJSI North America) for the ninth consecutive year.  DJSI North America analyzes companies on a variety of sustainability criteria, including economic performance, environmental stewardship and social responsibility. This adds to the recognition Medtronic received earlier this year through its continued inclusion in the FTSE4Good Index Series.

Medtronic is committed to advancing sustainability by strategically focusing on issues identified as most material to long-term success, including access to healthcare, product quality and patient safety, ethical business practices, responsible supply management, employee engagement and development, human rights, and environmental stewardship.

“We are honored to once again be recognized as a global leader in environmental, social, and corporate governance (ESG) initiatives.  Strong and sustainable ESG practices and our efforts to address chronic disease are important drivers of delivering long-term consistent growth for all of our stakeholders,” said Omar Ishrak, Medtronic chairman and CEO.  “We are pleased to be recognized for these efforts by our inclusion on the DJSI North America Index.”

As part of the company`s sustainability commitment to expand access to care worldwide, Medtronic leverages global partnerships that allow us to scale our impact and connect more patients with the care they need.

For information about Medtronic`s comprehensive sustainability efforts, please visit http://www.medtronic.com/us-en/about/citizenship.html and access our Integrated Performance Report.

Medtronic also continues to be recognized by the FTSE4Good Index and Corporate Responsibility Magazine`s 100 Best Corporate Citizens list, both announced earlier this year. Companies in the FTSE4Good Index Series have met stringent environmental, social and governance criteria, and are positioned to capitalize on the benefits of responsible business practices. More information can be found at
http://www.ftse.com/products/indices/FTSE4Good .

The Dow Jones Sustainability Indices were launched in 1999 as the first global sustainability benchmarks. More information about the DJSI can be found at sustainability-indices.com.

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world`s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic`s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

-end-

Contacts:

Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire

HUG#2040814

Angels invest in local medical device startup

By  – September 7, 2016

A Naples-based investment fund has bet its money on the success of a local orthopedic medical device startup.

The fund, Tamiami Angel Fund II, or T2 for short, has invested nearly $1 million in Catalyst OrthoScience to help the company ramp up the production of what it describes as a “breakthrough product” for shoulder-replacement surgery.

“The product we feel is revolutionary, not evolutionary. And we liked the progress that the management team had made,” said Tim Cartwright, chairman of Tamiami Angel Funds.

Steven Goldberg, chief of orthopedic surgery at Physicians Regional Healthcare System in Naples, founded Catalyst OrthoScience in December 2014. He started developing his product, called the Catalyst CSR Shoulder System, about four years ago. He has several patents for the device and others pending.

The device, which can fit in the palm of a hand, is made of two materials: a metal alloy, cobalt-chromium-molybdenum, and ultra-high molecular-weight polyethylene. It’s in the shape of a shoulder. Used with a new surgical approach, the implant requires less bone removal than other procedures for arthroplasty, or joint replacement.

T2 invested $930,000 in Catalyst OrthoScience. The fund was the lead investor in a $3.3 million Series A capital raise. Series A refers to the first significant round of capital raised from outside investors, and it’s the largest such raise in Southwest Florida this year, according to the MoneyTree Report from PricewaterhouseCoopers LLP.

Other investors in the new company include IrishAngels, a Chicago-based group whose members have ties to the University of Notre Dame.

Catalyst OrthoScience is one of two Naples-based companies T2 has invested in, and it’s one of the fund’s largest investments in a first round.

 

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Fractures That Fail to Heal May Be Predictable Based on Patient Risk Factors

September 08, 2016

DURHAM, N.C.–(BUSINESS WIRE)–Recent research has shed light on the predictability of fractures that fail to heal, known as nonunions. All nonunions are a function of severity, location and disease comorbidity and while risk factor interaction is complex, a new study reports that it may become possible to predict nonunion based on the patient-specific presentation of risk factors. The findings are published in the September 7, 2016 issue of JAMA Surgery available at http://archsurg.jamanetwork.com/article.aspx?articleid=2547685.

The study found that in 2011, among 309,330 fractures in 18 bones, the overall nonunion rate was 4.93%. However, higher nonunion risk was associated with severe fractures, high body mass index, smoking and alcoholism. While females had more fractures, males were more prone to nonunion. In addition, the risk of nonunion increased for patients who used certain medications including antibiotics, anticoagulants, and opioids, as well as for patients who had diseases such as obesity, osteoarthritis and osteoporosis.

“We hypothesized that the interplay between a patient’s physiological risk factors and fracture characteristics increased the risk of fracture nonunion,” said Dr. R. Grant Steen, Manager of Medical Affairs, Bioventus. “We now believe clinicians can use this information to describe the epidemiology of fracture nonunion in adult patients.”

The study was funded by Bioventus and used fracture patients from a health plan database. Patients with fracture were identified and continuous enrollment in the database was required for 12 months after fracture, to allow sufficient time to capture a nonunion diagnosis.

Authors of this study include Robert Zura, MD, LSU Health Science Center, New Orleans, Ze Xiong, MS, Dept. of Statistics, North Carolina State University, Thomas Einhorn, MD, NYU Langone Medical Center, J. Tracy Watson, MD Saint Louis University School of Medicine, Robert F. Ostrum, MD University of North Carolina, Michael J. Payson, MD, Wright State University, Gregory J. Della Rocca, MD, PhD, University of Missouri, Samir Mehta, MD, Hospital of the University of Pennsylvania, Todd McKinley, MD, Indiana University, Zhe Wang, MS, Dept. of Statistics, North Carolina State University and R. Grant Steen, PhD, Manager of Medical Affairs, Bioventus.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Post-operative use of PICO™ Single use Negative Pressure Wound Therapy improves predictability in wound healing and reduces complications following orthopaedic surgery

Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announces the publication of new clinical evidence highlighting improved patient outcomes following orthopaedic surgery.1

A Randomised Controlled Trial (RCT) of 220 patients undergoing primary hip or knee replacement compared the use of PICO, the novel Single use Negative Pressure Wound Therapy (NPWT) system, with standard dressings on closed surgical incisions. The research took place over a 12 month period at The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust (RJAH), Shropshire, UK. Results show significant reduction in; wound exudate distribution within the dressing, the number of dressing changes and extreme length of stay in hospital amongst those patients where PICO was applied.1

Whilst Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA) are commonplace procedures, reported figures of complications vary. Surgical site infection rate is suggested to be between 1-3% in the general orthopaedic population2, however UK Patient Reported Outcome Measures note that post-operative wound problems are recorded by approximately 10-13% of patients.3

Mr Sudheer Karlakki, lead RCT author and Consultant Orthopaedic Surgeon at RJAH, explains, “By introducing PICO as a prophylactic measure we have been able to demonstrate predictable wound healing following total hip and knee replacement procedures. Better wound management offers significant value to our hospital both in terms of reducing associated healthcare costs and by improving each patient’s outcome and experience.”

The impact of post-operative complications and prolonged wound exudate is serious and can lead to delayed discharge, increasing the care and cost burden to the hospital.4   The cost of any additional stay in a UK hospital is estimated at £275.00 per day, per hospital bed.1 Findings indicate that the use of PICO resulted in patients having a significantly smaller probability of experiencing excessive Length of Stay (LOS). The study showed a smaller range and spread of LOS in those patients with PICO compared to the standard dressing (1-10 days compared to 2-61 days).1   

The use of PICO resulted in a four-fold reduction in the number of patients experiencing Grade 4 distribution of wound exudate within the dressing when compared with standard wound dressing in those undergoing joint replacement.1 Prolonged wound drainage and high exudate levels increase the risk of wound complications by delaying healing, and have been associated with surgical site and deep prosthetic infections.1, 4

There was also a four-fold decrease (from 8% to 2%) in superficial surgical site complications.1 A further benefit was shown in the significant reduction in the number of total dressing changes required per patient using PICO. Fewer dressing changes may lead to greater patient comfort and less burden on nursing resource. Taking into account reduced LOS for the study group, lower wound complications, lower dressing changes and potential cost savings for wound care in the community due to reduced wound complications in the study group, the authors believes the cost of the PICO is justifiable.1

“Wound complications do not only impact the hospital, but they can have a devastating effect on a patient’s recovery,” explains Helen Griffiths, Outpatient Nurse at RJAH. “There is often a financial impact for the family as more time off work is required, not just for the patient but also their carer. High levels of wound exudate or infections can also cause embarrassment and discomfort, often resulting in significant anxiety. PICO can help prevent these issues through improved wound healing and increased patient confidence.”

While significant benefits have been demonstrated for patients across all demographics, statistical analysis suggests that the use of PICO as a prophylactic for closed surgical incision management in patients that are categorised as high risk (BMI >35, ASA >3 or, diabetics is particularly beneficial.1

The full study is published in Bone and Joint Research in August 2016 and is available on their website.

Mr Sudheer Karlakki will be presenting the results of the RCT at the European Bone and Joint Infection conference in September.

Enquiries

Media

Beth Lowes or Rachel Cunningham
ROAD Communications on behalf of Smith & Nephew
+44 (0)208 995 5832
firstname@roadcommunications.co.uk

About the study

This Investigator Initiated Study (IIS) was performed at Robert Jones and Agnes Hunt Orthopaedic Hospital in which Smith and Nephew Wound Management provided funding and devices, which sought to determine whether the use of a incisional Negative Pressure Wound Therapy (PICO, Smith & Nephew) could give predictable length of stay by improved management of the incisional wound after planned primary joint replacement surgery. This was a 220 patient Randomised Controlled Trial (RCT) of PICO, compared to standard dressings. The PICO group showed an improvement in all areas investigated compared to standard care control group.

About PICO

PICO is cleared for use in hospital and homecare settings in Europe, US, Canada, and Australia. In Japan PICO is cleared for use in open wounds only.For more information about the PICO system and the NPWT portfolio of products from Smith & Nephew, please visit www.smith-nephew.com. Clinicians and patients may also refer to the 24/7 Negative Pressure Wound Therapy hotline, 0800 9155394 (UK) and 1800 303 622 (Ireland)

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management,Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Smith & Nephew will be presenting more of the latest research on surgical site complications at WUWHS 2016. To learn more go to http://www.smith-nephew.com/wuwhs2016/.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

◊Trademark of Smith & Nephew.

©July 2016 Smith & Nephew 75112

References

Additive Orthopaedics Announces the 510(k) Clearance of Their 3D Printed Osteotomy Wedge System for the Global Extremities Market

LITTLE SILVER, N.J., Sept. 8, 2016 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed osteotomy wedge system, to address bone fractures or osteotomies in the foot and ankle. This is the Company’s second innovative device leveraging additive manufacturing that has been cleared through the FDA.

According to Dr. Selene Parekh, Professor of Surgery in the Department of Orthopaedic Surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic, “The complex geometry and unique lattice structure, which is only possible through the use of 3D printing technology, should have tremendous patient benefits.  Solutions like these, as well as custom and patient specific applications of this technology, will continue to have a major impact on how we treat our patients.”

About Additive Orthopaedics, LLC.
Additive Orthopaedics is an early stage orthopaedic company focused on leveraging the patient, technological and cost benefits of additive manufacturing into the global extremities market.

Contact:
Greg Kowalczyk
732.882.6633
greg@additiveortho.com

Logo – http://photos.prnewswire.com/prnh/20160601/374308LOGO

SOURCE Additive Orthopaedics, LLC.

Zimmer Biomet Earns EPA Recognition for Converting Warsaw-Indiana Headquarters to 100-Percent Green Power

WARSAW, Ind., Sept. 7, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Warsaw, Indiana-based headquarters will be wholly powered by renewable, green energy, in compliance with the U.S. Environmental Protection Agency’s(EPA) Green Power Partnership program. Green power is zero-emissions electricity that is generated from environmentally preferable renewable resources, such as wind, solar, geothermal, biogas, eligible biomass, and low-impact hydro. Zimmer Biomet’s headquarters building will receive green power from Northern Indiana Public Service Company (NIPSCO), an approved provider of green power for the EPA’s Green Power Program, which allows homes and businesses to designate a portion, or all, of their monthly electric usage to be attributable to electricity generated by renewable energy sources.

“We are proud to partner with the EPA and NIPSCO to lead the green power revolution in Indiana by converting 100 percent of our headquarters’ power consumption to renewable energy sources,” said Robin T. Barney, Senior Vice President, Global Operations and Logistics.  “Sustainably and responsibly sourcing our electric power is a critical milestone in advancing Zimmer Biomet’s longstanding commitment to sustainability, and we hope our efforts inspire local area businesses and residents to join the EPA’s Green Power Program to collectively reduce our region’s environmental footprint.”

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; spine, bone healing, 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.

About NIPSCO
Headquartered in Merrillville, Indiana, NIPSCO has proudly served the energy needs of northern Indiana for more than 100 years.  As Indiana’s largest natural gas distribution company and the second largest electric distribution company, NIPSCO serves approximately 810,000 natural gas and 460,000 electric customers across 32 counties. NIPSCO is part of NiSource’s seven regulated utility companies. NiSource is one of the largest fully regulated utility companies in the United States, serving approximately 4 million natural gas and electric customers through its local Columbia Gas and NIPSCO brands. More information about NIPSCO and NiSource is available at NIPSCO.com and NiSource.com.

For more information or to enroll in the Green Power Program, please visit NIPSCO.com/GreenPower or call 1-(800)-4NIPSCO (464-7726).

About EPA’s Green Power Partnership
The Green Power Partnership is a voluntary program that encourages organizations to use green power as a way to reduce the environmental impacts associated with electricity use. The Partnership currently has more than 1,400 Partner organizations voluntarily using billions of kilowatt-hours of green power annually. Partners include a wide variety of leading organizations such as Fortune 500® companies; small and medium sized businesses; local, state, and federal governments; and colleges and universities. For additional information, please visit www.epa.gov/greenpower.

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

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SOURCE Zimmer Biomet Holdings, Inc.

News Provided by Acquire Media

In2Bones USA Completes Merger to Form i2b Global

September 07, 2016

MEMPHIS, Tenn. & LYON, France–(BUSINESS WIRE)–In2Bones USA, LLC and In2Bones, SAS announced today that the two companies have completed a series of transactions which will combine, pursuant to an all-stock share exchange, In2Bones, SAS with its largest distributor, In2Bones USA, LLC.

The merger officially closed on August 31, 2016.The merged companies have become wholly-owned subsidiaries of a holding company known as In2Bones Global, Inc. (dba: i2b Global), creating a global company specializing in the fast-growing upper and lower extremities orthopaedic markets.

i2b Global will continue to operate both of its subsidiaries in Memphis, Tenn., and Lyon, France. The corporate headquarters for i2b Global will be based in Memphis.

“The two companies have shared a distribution and development relationship for several months. This merger allows us to better coordinate product development and distribution around the world,” says Alan Taylor, orthopaedic industry veteran and President and Chief Executive Officer of i2b Global.

“We have known for some time that we needed to combine the companies in order to add scale and efficiencies for our rapidly expanding enterprise,” says Eric Fourcault, a founder of In2Bones and head of the company’s Lyon, France and non-U.S. interests. “We believe this action will further accelerate our growth in the global market.”

For more information about i2b Global extremity products in the U.S. and France, please visit www.i2b-USA.com or www.In2Bones.com.

About In2Bones USA, LLC

In2Bones USA, LLC is a designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. The company currently markets more than 12 products in the United States and has a product pipeline of 10 to 12 additional products slated for launch in the remainder of 2016 and 2017. For more information, visit www.i2b-USA.com.

About In2Bones, SAS

Located in Lyon, France, In2Bones, SAS is a specialty orthopaedic company that develops and distributes upper and lower extremity products to enable surgeons to alleviate pain and restore motion for their patients. For more information, visit www.In2Bones.com.

Safe-Harbor Statement:

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

Contacts

Element-R Partners
Susan Duensing, CBC
847.639.8300
susan@rurelevant.com

Best Hospitals for Orthopedics

New York, NY
#1 in Adult Orthopedics Hospitals 
Hospital for Special Surgery in New York, NY is nationally ranked in 2 adult specialties.
100.0/100  – Overall Score    5/5  – Safety Score    201 – Doctors in Specialty
Rochester, MN
#2 in Adult Orthopedics Hospitals
Mayo Clinic in Rochester, MN is nationally ranked in 15 adult specialties and 8 pediatric specialties.
86.9/100 – Overall Score    5/5 – Safety Score    253  – Doctors in Specialty

Cleveland Clinic

Cleveland, OH

#3 in Adult Orthopedics Hospitals
Cleveland Clinic in Cleveland, OH is nationally ranked in 14 adult specialties and 9 pediatric specialties.
76.7/100 – Overall Score     5/5 – Safety Score     158 – Doctors in Specialty
Chicago, IL
#4 in Adult Orthopedics Hospitals
Rush University Medical Center in Chicago, IL is nationally ranked in 9 adult specialties.
73.6/100 – Overall Score     4/5 – Safety Score      95 – Doctors in Specialty

New York, NY

#5 in Adult Orthopedics Hospitals

NYU Langone Medical Center in New York, NY is nationally ranked in 12 adult specialties.

72.1/100 – Overall Score        4/5 – Safety Score       209 – Doctors in Specialty

 

FIND THE REST HERE

 

Flower Orthopedics Debuts Next Generation Ready-for-Surgery™ Guide Wire Kits

HORSHAM, Pa., Sept. 7, 2016 /PRNewswire/ — Flower Orthopedics announces the full market launch of its next generation Ready-for-Surgery™ Guide Wire Kits for the Cannulated Screw FlowerCube™. The patent-pending Flower Guide Wire Kits reduce the number of surgical steps and are evidence of Flower’s continuing commitment to develop products that provide enhanced surgical efficiency in the OR.

“With the countersink and depth gauge combined in one instrument, Flower Orthopedics is providing solutions to surgeons that streamline the process of treating patients with internal fixation,” says Dr. Timothy Mineo of Portland, Oregon.

Flower is redefining the orthopedic extremity and trauma marketplace with its Ready-for-Surgery™ implants and instruments in the efficient FlowerCube™ system.  “In developing the next generation of Guide Wire Kits, the engineering team was able to improve a surgical process with elegance, maintaining our surgical efficiency objective and compounding our product differentiation within the marketplace,” adds Oliver Burckhardt, CEO & President of Flower Orthopedics.

Like all Flower products, the new Guide Wire Kits are single-use, sterile packaged and always Ready-for-Surgery™.

Flower Orthopedics: Surgical Efficiency Drives Healthcare Costs Savings

Whether it is addressing infection potential, eliminating set reprocessing expenses or preventing delays in the OR, the Flower Orthopedics Ready-for-Surgery™ portfolio is a proven method that surgeons and healthcare facilities use to reduce the overall cost of providing patient care.  Flower development team works tirelessly with leading surgeons to decrease the number of surgical steps of a given procedure and to design instruments that make surgeries faster and more reproducible. Combining the surgical efficiency with the inherent efficiencies of the Ready-for-Surgery™ model, Flower Orthopedics is reducing the cost of care for a wide range of extremity applications.

Please refer to www.flowerortho.com for the Indications for Use

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/flower-orthopedics-debuts-next-generation-ready-for-surgery-guide-wire-kits-300323850.html