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MedShape Announces FDA Clearance for the DynaNail® XL

Posted On November 15, 2017 By OrthoSpineNews In Regulatory /  

ATLANTA, Nov. 14, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DynaNail® XL TTC Fusion System. The DynaNail XL is available in 260mm and 300mm lengths, thus expanding the product’s use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM) nail. The DynaNail XL will be launched in early 2018.

Indicated for tibiotalocalcaneal (TTC) fusion surgery, the DynaNail XL was developed in response to surgeon demand for an IM nail that better accommodates longer patient tibial anatomies or when tibial fractures are present. Its longer length in combination with DynaNail’s pseudoelastic NiTiNOL Element could help reduce stress risers in the bone, consequently lowering the chance for tibial fractures.1 DynaNail XL features a similar design as the original 220 mm version but also has a proximal taper for easy insertion through the tibial isthmus and an extra proximal screw hole for an optional cortical screw for additional stability.

Clinically introduced in 2012, the DynaNail is the first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL to provide the compression performance of an external frame inside an IM nail design. Compression has shown to be important not only in keeping the bones in close apposition but also in providing the physiological stresses needed to promote bone healing.  Like the original 220mm version, the DynaNail XL features an internal NiTiNOL Compressive Element that maintains post-operative compression for up to 6 mm of bone resorption and settling. The DynaNail Compressive Element also allows for effective load sharing across the bone due to its axial compliance during weight-bearing.2 To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic.3,4,5

The FDA clearance of the DynaNail XL closes out a year noted by several updates to the DynaNail product line. In June, the DynaFrame™ Carbon-Fiber (CF) Deployment System was launched, providing surgeons with a simple, robust method to insert the DynaNail and activate the NiTiNOL element during surgery. This was followed by the release of new instrument sets to accommodate the increased demand. Finally, with the DynaNail XL, MedShape also gained clearance to offer a new alternate surgical technique that allows for a more streamlined approach and the option for automatic dynamization once the NiTiNOL Element has fully recovered.

“The recent additions to the DynaNail portfolio demonstrate our continued commitment toward improving upon the success of the company’s flagship product,” said Kurt Jacobus, MedShape CEO. “We have been pleased with the growing adoption of this unique technology by both orthopaedic surgeons and podiatrists and anticipate continued growth with these new offerings.”

About MedShape, Inc.

MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions for foot and ankle and trauma surgeons that use its patented advanced material technologies. For more information, visit: www.medshape.com.

1Catanzariti, A. R., DPM, & Mendicino, R. W., DPM. (2009). Intramedullary Nail Fixation for Reconstruction of the Hindfoot and Ankle in Charcot Neuroarthropathy. In Surgical Reconstruction of the Diabetic Foot and Ankle (pp. 241-254). Philadelphia: Wolters Kluwer.

2Anderson RT, Pacaccio DJ, Yakacki CM, Carpenter RD. Finite element analysis of a pseudoelastic compression-generating intramedullary ankle arthrodesis nail. J Mech Beh Biomed Mat, 2016; 62: 83-92.

3Kreulen C, Lian E, Giza E. Technique for Use of Trabecular Metal Spacers in Tibiotalocalcaneal Arthrodesis with Large Bony Defects. Foot Ankle Int, 2017; 38(1): 96-106.

4Latt LD, Dupont KM, Smith KE. Revision Tibiotalocalcaneal Arthrodesis with a Pseudoelastic Intramedullary Nail – A Case Study. Foot Ankle Spec; 2017; 10(1): 75-81.

5Hsu AR, Ellington JK, Adams SB, Jr. Tibiotalocalcaneal Arthrodesis Using a NiTiNOL Intramedullary Hindfoot Nail. Foot Ankle Spec 2015; 8(5): 389-96.

DynaNail and DynaFrame are a registered trademark and trademark of MedShape, Inc, respectively.

Media Contact:
Jenn Pratt
Carabiner Communications
678.313.3438
jpratt@carabinercomms.com

Company Contact:
Kathryn Smith, Ph.D.
678.235.3304
Kathryn.smith@medshape.com

 

SOURCE MedShape, Inc.

Related Links

http://www.medshape.com

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New England Baptist to open spine center thanks to largest donation in its history

Posted On November 14, 2017 By OrthoSpineNews In Spine, Top Stories /  

11-14-2017 – By   –  Reporter, Boston Business Journal

New England Baptist Hospital will create a new spine institute, thanks to a $3 million gift from one of its board members.

Jeffrey Libert, a trustee of the hospital, recently gifted the hospital $3 million on behalf of his family to form the Libert Family Spine Institute, which will look to create a new singular door for patients suffering from back pain and find approaches and treatments beyond surgical interventions.

The donation is the largest in the hospital’s history, and is on top of $2 million Libert had already donated to the hospital for medical education and research.

“With the largest number of spine surgery patients regionally, and a significant volume of non-surgical patients, NEBH is uniquely positioned to enhance clinical care by leveraging data with predictive analytics to improve existing treatments and design better options for patients with spine disease or injury,” said Dr. Scott Tromanhauser, chief of spine surgery, chief medical quality officer and director of research administration for the hospital, in a statement. “By establishing this institute, we will be able to make a significant difference in how back pain is treated.”

 

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IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

Posted On November 14, 2017 By OrthoSpineNews In Extremities, Regulatory, Top Stories /  

LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread™ Fibula Pin System.

The IntraFuse FlexThread™ Fibula Pin System provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures.  The simple and elegant design is easy to insert and cost competitive with today’s standard-of-care internal fixation hardware. Incorporating IntraFuse’s proprietary FlexThread™ technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod.  Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal.  With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period. Additionally, the FlexThread™ Fibula Pin is compatible with either screw or flexible fixation of the syndesmosis joint as needed.

To accommodate the anatomic size range of fibulas, the FlexThread™ Fibula Pin is available in three different screw diameters, each with two length options.  Using routine intramedullary and screw fixation techniques, bone preparation is a simple, three step sequence:  place guide wire, ream, tap.   Optional fracture site compression is achieved concurrent with insertion of the implant, and delivery of cross fixation screws is facilitated by a guide that connects directly to the implant inserter.

The FlexThread™ Fibula Pin provides anatomic, intramedullary fixation that may have potential clinical advantages over fibula plating systems, including: reduced risk of hardware related pain, reduced rate of hardware removal, less risk of wound complications, infection and other morbidities due to a less invasive procedure, and less disruption of the periosteum which facilitates faster healing.

“Intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities,” states Wade Fallin, CEO of IntraFuse.  Fallin continues, “FlexThread™ is a platform technology that can address the unique requirements for intramedullary fixation of small bone fractures where off-axis entry into the bone canal is required, or where the bone is curved.  Now cleared for both clavicle and fibula fractures, the FlexThread™ technology is in further development for additional indications.”

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

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Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair System

Posted On November 14, 2017 By OrthoSpineNews In Extremities, Regulatory, Top Stories /  

LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative SyndesMetricsÔ Syndesmosis Repair System.

The Mortise Medical SyndesMetricsÔ Syndesmosis Repair System was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability.  Anatomic reduction is achieved using the SyndesMetricsÔ Reduction Clamp, which features: anatomic referencing clamp points; precision, surgeon controlled, calibrated clamping force; and an integrated drill guide to prepare the bone for the SyndesMetricsÔ  implant system.  Both the SyndesMetricsÔ Reduction Clamp and implant system are compatible with distal fibula plating systems.  Also, the SyndesMetricsÔ implant system features minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.

Based on biomechanical testing on matched pair human cadaveric ankle specimens at the University of Iowa, the SyndesMetricsÔ implant system was found to more closely reproduce normal physiological ankle motion when compared to a 4.5mm cortical screw or a suture button construct.1  Additionally, mechanical testing conducted by a third party medical device testing company demonstrated that SyndesMetricsÔ repair constructs had higher static strength and higher fatigue strength than 3.5mm cortical screw or suture button repair constructs.2

“Surgeons will find this innovative system more intuitive to use and more reproducible for positioning and tensioning the distal tibiofibular syndesmosis than anything we now have available,” states Dr. Charles L. Saltzman, Professor and Chairman of Orthopaedics at the University of Utah and immediate past President of the International Federation of Foot and Ankle Societies.

Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.

1 Goetz JE, et al., Annual Meeting of the American Society of Biomechanics, 2017

2 Data on file

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

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Russo Partners Teams with Medovex to Highlight Medical Technology Innovation with DenerveX System

Posted On November 14, 2017 By OrthoSpineNews In Spine /  

NEW YORK, Nov. 13, 2017 /PRNewswire/ — Russo Partners LLC and Medovex Corp. (NASDAQ: MDVX) have teamed to call attention to the need for new treatments for chronic back pain and the Company’s innovative solution known as the DenerveX® System. Currently approved for use outside of the U.S., DenerveX is a new device designed to enable doctors to provide patients with enduring relief of back pain caused by Facet Joint Syndrome.

The Medovex public relations initiatives include an extensive video campaign featuring spine surgeons worldwide. Wilcots, an NFL broadcaster, former professional football player and leader of Russo Partners’ Sports-Health Alliance, recently interviewed doctors at the EUROSPINE 2017 annual meeting in Dublin and the North American Spine Society (NASS) conference in Orlando, where he also taped a demonstration of the DenerveX System in use in a surgical cadaver lab. Russo Partners and Medovex will integrate the content into ongoing social and traditional media initiatives this quarter as Medovex continues its country-by-country roll-out of the medical technology.

“Solomon has the natural ability to bring professionals together and craft medical stories in a natural and impactful manner,” said Patrick Kullmann, president and COO of Medovex. “We look forward to using the output of his work to increase the visibility and awareness of what we are doing at Medovex to transform how surgeons and pain management physicians treat a common source of chronic back pain. This is a meaningful change with our DenerveX system that is focused on long-term relief.”

Wilcots added, “Chronic back pain, including that caused by Facet Joint Syndrome, is common among former professional athletes. The opportunity presented by the DenerveX System is one of giving people back quality of life without reliance on prescriptive pain relief medicines. This is exciting technology about which physicians were eager to speak with me and share their perspectives on how it will change their practices and patients’ lives. We will continue with these initiatives throughout 2018.”

The DenerveX System is a non-addictive opioid drug alternative capable of restoring a patient to a more normal and active lifestyle. It was designed by medical professionals for medical professionals to enhance a patient’s quality of life. Using highly differentiated technology, the DenerveX System denervates and removes capsular tissue from the facet joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and radio frequency ablation treatment on the facet joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint. To learn more about the DenerveX System, visit http://medovex.com/us/denervex-system/.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in countries worldwide, including the U.S. and countries in the EU. This condition affects millions of people each year, and current treatment options are generally temporary with no proven long-lasting option.

About Medovex

Medovex Corp. was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with Facet Joint Syndrome at significantly less cost over time than currently available options. To learn more about Medovex, visit www.medovex.com.

About Russo Partners’ Sports-Health Alliance

The Sports-Health Alliance is an award-winning public relations service at the intersection of health, medicine and sports. Launched by Russo Partners in 2017, this offering leverages the agency’s inside access to athletes, broadcasters and sports business leaders who have a shared passion with their clients for a disease or treatment. The Alliance was cultivated over a two-year span and involves Russo Partners’ Team Leader Solomon Wilcots. Visit https://russopartnersllc.com/services/sports-health-alliance/ for more information.

About Russo Partners

Since 1988, Russo Partners, formerly Noonan/Russo Communications, has provided public and investor relations and corporate communications services to both emerging and established healthcare and technology-centric companies worldwide. The agency’s staff is comprised of senior executives with extensive backgrounds in science, medicine, finance and communications. Visit www.russopartnersllc.com for more information.

CONTACT INFORMATION

Medovex Corp.
Jason Assad
470-505-9905
Jassad@medovex.com

GLOBAL MEDIA CONTACTS

David Schull
Russo Partners LLC
212-845-4271 (office)
858-717-2310 (mobile)
David.schull@russopartnersllc.com

Caroline Cunningham
Russo Partners LLC
212-845-4292 (office)
203-969-4308 (mobile)
Caroline.cunningham@russopartnersllc.com

SOURCE Russo Partners, LLC

Related Links

http://www.russopartnersllc.com

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SpineGuard and XingRong Medical launch PediGuard® in China

Posted On November 14, 2017 By OrthoSpineNews In Spine, Top Stories /  

November 13, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today that XinRong Medical Group will officially launch the Classic PediGuard product range in China during the Chinese Orthopedic Association (COA) annual meeting being held in Zhuhai, China from November 15-18.

The COA meeting is the largest and most influential Orthopedic Surgery Society in China with 14 sub-specialties such as spine surgery. This annual meeting is widely attended by Chinese surgeons (over 21,000 attendees in 2016) and is a unique opportunity to launch the PediGuard®. Over recent years, the Chinese orthopedic market has become the second largest in the world, after the USA.

On November 16th, XinRong Medical Group will offer a PediGuard® workshop at their booth #3A11 with Prof. Chen Zhong Quing (China), Prof. Wong Hee Kit (Singapore) and Prof. Liang Yu (China) as faculty.

“We believe the COA annual meeting is the best congress with the right timing to launch the PediGuard® in China. The workshop given by XinRong Medical Group will be the opportunity for the Chinese spine surgeons who have been waiting for SpineGuard’s DSG™ technology since its clearance by CFDA, to learn more about the products from experienced key opinion leader surgeons and facilitate first use. We are delighted by the collaboration with our very dynamic partner XinRong and are looking forward to supporting our common success in China with PediGuard®” said Stéphane Bette, CEO and co-founder of SpineGuard.

“We are very excited to hold the official PediGuard® China Launch Meeting during COA supported by top key opinion leaders in spine surgery in China. PediGuard® can alert surgeons of potential pedicular or vertebral breaches and provides real-time feedback through audio and visual signals. With the introduction of this device, we could help Chinese surgeons reduce the risk of pedicle screw misplacement and dramatically improve outcomes for patients. Moreover and looking forward, SpineGuard has received the patent for its smart screw concept integrating its DSG™ sensor into the implantable pedicle screw through imbedding electronics into the screwdriver handle, opening new opportunities for further collaborations.”, added Christine Zhang, XinRong Medical Group’s CEO.

More information on the DSG™ technology and surgeons’ testimonials here.

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About XinRong Medical Group
XinRong Medical Group, a leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solutions for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopedic surgery, neurosurgery, reconstructive surgery, and minimally invasive therapy. Established in 2000 in Jiangsu Province, China, XinRong Medical was one of the first companies in China cleared by CFDA to manufacture Orthopedic Implants. In 2014, the Company received a strategic investment from The Blackstone Group (NYSE: BX). For additional information about XinRong Medical, please refer to our website www.XRBest.Com, or contact us directly at +86-512-58100828 or info@xrmed.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0) 1 45 18 45 19
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
Tel: +33 (0)1 45 18 45 19
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

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OrthoPediatrics Corp. to Start Distributing Bioretec Devices via Private Label

Posted On November 13, 2017 By OrthoSpineNews In Biologics, Extremities, Sports Medicine, Top Stories /  

WARSAW, Ind., Nov. 13, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, and Bioretec Ltd. (“Bioretec”), announced today that they have amended their existing distribution agreement in order for OrthoPediatrics to market and sell Bioretec’s unique, bioresorbable orthopaedic bone and soft-tissue fixation implants under the OrthoPediatrics brand, TorqLoc™. Bioretec’s bioresorbable implants are ideal for repairing musculoskeletal defects of children and young people. Treatment of musculoskeletal defects and trauma related bone and soft-tissue injuries are steadily increasing, as well as the need for surgeries related to treating such conditions. Bioretec’s fully bioresorbable implants have shown excellent results in repairing the growing bones of children and young people.

“We are excited to start OrthoPediatrics’ private label collaboration, whose enthusiasm towards developing and improving surgical care for children, we admire.  Our products are ideal for surgeries of children, since the bioresorption of our implants eliminates the need for secondary removal operation after the healing of musculoskeletal tissues. This is especially important with children, for whom the risks and inconveniences associated with surgical procedures are much higher,” commented Tomi Numminen, CEO of Bioretec.

OrthoPediatrics’ Vice President for Trauma & Deformity Correction, Joe Hauser, added, “This evolving strategic partnership and collaboration with Bioretec represents another area for tremendous growth within OrthoPediatrics’ portfolio.  The TorqLoc™ screw portfolio will provide a truly innovative option for many unmet pediatric orthopedic sports and tissue repair surgical needs.  In addition to OrthoPediatrics’ all epiphyseal ACL system, we now can help our surgeon partners with MPFL, foot, shoulder, and hand solutions by providing this new generation bioabsorbable implant offering.”

About Bioretec
Bioretec Ltd. is a Finnish material technology company focused on the development, manufacturing and marketing of bioabsorbable, bioactive and drug-releasing surgical implants for orthopedic, trauma and sport medicine surgeries. Bioretec implants, designed and manufactured in Finland, have been used in 33 countries, including United States, China, Russia, UK, Germany, Italy and Spain.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

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TransEnterix Announces Senhance US Sale Agreement With Florida Hospital

Posted On November 13, 2017 By OrthoSpineNews In Robotics /  

November 13, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that Florida Hospital entered into an agreement to purchase the Company’s Senhance™ Surgical Robotic System.

The Florida Hospital Orlando campus will be home to the first commercial unit of the Senhance Surgical System to be installed in the United States.

Now available in the United States, the recently FDA-cleared Senhance Surgical System represents an innovative technology designed to assist surgeons in performing minimally invasive surgery. The system features multiple robotic arms that are controlled by a surgeon seated comfortably at a console. The surgeon controls small surgical instruments with robotic precision while at the same time moving a small scope that tracks the eye movement of the surgeon. The Senhance is the first surgical robotic system to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. The Senhance represents a new era of digital laparoscopy designed to support responsible economics for the hospital, patient and today’s value-based healthcare system.

“We are pleased to announce our first US sale of the Senhance Surgical System,” said Todd M. Pope, President and CEO at TransEnterix. “Florida Hospital is a global leader in the application of next generation technologies to care for patients. It’s fitting that Florida Hospital will be the first in the United States to adopt this technology for patient care.”

“The digital operating room of the future has arrived, and our surgeons will continue to be leaders in applying robotic technology, like the Senhance, to benefit our patients across a full range of procedures and specialties,” said Dr. Steve Eubanks, surgeon and Executive Medical Director for the Institute for Surgical Advancement at Florida Hospital. “Our team of clinicians selected the Senhance Surgical System to further our minimally invasive offerings. We believe this robotic system will support our surgeons in maximizing their precision and control during procedures while minimizing costs.”

About Florida Hospital

Florida Hospital is a member of Adventist Health System, which operates 45 hospitals in 9 states, making it one of the largest not-for-profit healthcare systems in the United States, caring for more than 5 million patients annually. Florida Hospital continues to be at the forefront of health-care innovation. In addition to the Florida Hospital Institute for Surgical Advancement, it’s also home to the Florida Hospital Nicholson Center, a facility specializing in training surgeons from around the globe on the latest surgical technology and techniques, and the Global Robotics Institute, a world leader in the robotic-assisted treatment of prostate cancer.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance Surgical Robotic System will benefit Florida Hospital’s patients and whether the Senhance Surgical Robotic System will support Florida Hospital’s surgeons in maximizing their precision and control during procedures while minimizing costs. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.com

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Trump picks Alex Azar to lead the Health and Human Services Department

Posted On November 13, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

By Juliet Eilperin and Amy Goldstein / November 13, 2017

President Trump has selected Alex Azar, a former pharmaceutical executive and a top health official during the George W. Bush administration, to lead the Health and Human Services Department.

The decision to enlist the 50-year-old Azar — who served as president of Lilly USA, the biggest affiliate of Eli Lilly and Co., before stepping down in January to work as a health-care consultant — represents a pragmatic pick. An establishment figure with a reputation as a conservative thinker and methodical lawyer, Azar would be expected to use his experience as HHS general counsel and deputy secretary to pursue Trump’s goals through executive action.

In announcing the nomination Monday morning, Trump tweeted that Azar “will be a star for better healthcare and lower drug prices!” He has a close rapport with the department’s top political appointees as well as Vice President Pence.

Azar has been highly critical of the Affordable Care Act, telling Fox Business in May that the law was “certainly circling the drain” and saying in a speech two months ago that many of its problems “were entirely predictable as a matter of economic and individual behavior.”

In a June interview on Bloomberg Television, Azar made it clear he thought the administration could shift the ACA in a more conservative direction even if congressional Republicans failed to repeal much of it. “I’m not one to say many good things about Obamacare, but one of the nice things in it is it does give tremendous amount of authority to the secretary of HHS,” he said.

He also supports converting Medicaid from an entitlement program covering everyone who is eligible into block grants, a long-standing GOP goal that has sparked opposition from Democrats as well as some centrist Republicans. He has opposed expanding the program under the ACA to people with slightly higher incomes.

The nominee boasts sterling conservative credentials, clerking for the late Supreme Court Justice Antonin Scalia before working under special counsel Kenneth Starr to investigate Bill Clinton’s failed Whitewater real estate investments. Still, administration officials think he could work more deftly with competing health-care interests and politicians than his predecessor, Tom Price.

 

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Smith & Nephew’s NAVIO™ Surgical System launches the first robotics-assisted bi-cruciate retaining total knee replacement

Posted On November 13, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /  

13 November 2017

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announces completion of the world’s first robotics-assisted bi-cruciate retaining total knee replacement procedures.

The NAVIO robotics-assisted surgical system aids in implanting the JOURNEY™ II XR (bi-cruciate retaining total knee system) which is one of the only total knee designs allowing retention of the ACL, and is designed to improve patient satisfaction. 1

With this launch, NAVIO now offers both partial and total knee options that include the first and only robotics-assisted bi-cruciate retaining knee procedure, commercially available today.

Drs. Vivek Neginhal (WV), David Rovinsky(HI), and David Fabi (CA) recently performed the first cases. “I believe that the NAVIO is able to provide critical elements of success for the JOURNEY II XR, such as accuracy of tibia component placement and a streamlined surgical technique.” Dr. Neginhal further commented: “I was amazed at how fluid the knee motion was on the first postop day. My patients have expressed great satisfaction so far. I believe that NAVIO’s accuracy and flexibility of use combined with JOURNEY II XR’s retention of the patient’s cruciate ligaments and physiological design will truly increase patients’ function and satisfaction.”

The NAVIO is a next generation handheld robotics platform designed to aid surgeons with implant alignment, ligament balancing and bone preparation – key factors that can drive implant survivorship.2,3 The small footprint of NAVIO allows for set up and portability. Furthermore, the NAVIO robotics-assisted system does not require a preoperative image, such as a CT scan. This allows patients to receive the benefits of robotics-assistance without the extra steps, costs, and radiation associated with additional preoperative imaging.4

“The JOURNEY II XR bi-cruciate retaining knee has the potential to deliver the best possible outcome for the surgeon and patient through the preservation of important anatomical structures such as the ACL. The NAVIO robotics-assisted surgical system enables accurate tibial implant placement to deliver a more reproducible surgical technique. We are proud to be the only company to offer the unique combination of NAVIO robotics-assistance and the JOURNEY II XR Knee System,” said Mike Donoghue, Senior Vice President of Global Marketing, Orthopaedics at Smith & Nephew.

References

  1. Moro-Oka, Taka-Aki, Marc Muenchinger, Jean Pierre Canciani, and Scott A. Banks.“Comparing in Vivo
    Kinematics of Anterior Cruciate-retaining and Posterior Cruciate-retaining Total Knee Arthroplasty.” Knee
    Surgery, Sports Traumatology, Arthroscopy 15.1 (200&): 93:99. Web.
  2. Sharkey, P., et al. “Why Are Total Knee Arthroplasties Failing Today?” Clinical Orthopaedics and Related Research. 2002 Nov;404:7-13.
  3. Siddique, N., Ahmad, Z. “Revision of Unicondylar to Total Knee Arthroplasty: A Systematic Review” The Open Orthopaedics Journal 2012;6; (Suppl 2: M2) 268-275
  4. Sg2 Healthcare Intelligence. Technology Guide: Orthopedic Surgical Robotics. 2014.25. Readmissions Reduction Program (HRRP). CMS.gov. Page last Modified: 04/18/2016 5:08 PM.

Enquiries

Media  
Charles Reynolds +44 (0) 1923 477314
Smith & Nephew
Dave Snyder +1 (978) 749-1440
Smith & Nephew
Simon Conway / Debbie Scott +44 (0) 20 3727 1000
FTI Consulting

 

Investors  
Ingeborg Øie +44 (0) 20 7960 2285
Smith & Nephew

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 2016 were almost $4.7 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.

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.

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