Wenzel Spine Announces Acquisition of Interspinous & Facet Fixation Product Platforms

Posted On February 22, 2017 By OrthoSpineNews In Spine /  

February 22, 2017

AUSTIN, Texas–(BUSINESS WIRE)–

Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced that it has completed the acquisition of the PrimaLOK™ SP Interspinous Fusion System and PrimaLOK™ FF Facet Fixation System from OsteoMed, LLC.

The PrimaLOK SP & FF platforms include a polyaxial interspinous process device and percutaneous facet screw system designed for MIS applications in treatment of lumbar spinal disorders. These patented technologies are designed to provide surgeons an expanded MIS solution when used in conjunction with the stand-alone, expandable, VariLift-LX interbody fusion device.

“This acquisition provides our distributors and surgeons a powerful combination of MIS solutions. When paired with our VariLift-LX stand-alone, expandable, interbody technology, surgeons now have the ability to provide supplemental fixation, when needed, without having to revert to pedicle screw constructs,” said Chad Neely, President and Chief Executive Officer of Wenzel Spine. “In addition, this expands our current product portfolio while strengthening our development pipeline and demonstrating our commitment to the development of innovative MIS solutions to our distribution and surgeon partners.”

Dr. Charles Gordon, the inventor of the PrimaLOK SP System, and founder of the Texas Spine & Joint Hospital, commented, “I am pleased that Wenzel Spine has added the PrimaLOK Systems to their product portfolio. We are very happy to be partnered with a Spine focused company and believe Wenzel Spine is the ideal partner to bring the full potential of the PrimaLOK Systems to market.” Dr. Gordon further commented, “There are tremendous MIS innovation opportunities in combining the advantages of the PrimaLOK and VariLift-LX technologies.”

Wenzel Spine plans to integrate the PrimaLOK platforms into the pipeline of innovative MIS solutions currently being developed. The company has completed a limited US release of the PrimaLOK SP & FF Systems and expects to offer wide US release of the products in the second quarter of 2017.

About Wenzel Spine, Inc.

Wenzel Spine, Inc. is a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders. Headquartered in Austin, TX, Wenzel Spine is focused on delivering surgical solutions that improve the overall quality of spine care by simplifying procedures and reducing recovery time. Wenzel Spine seeks to improve patient quality of life by designing and producing devices of the highest quality to support our surgeon clients in the care and treatment of their patients. For more information about the company and our products, visit www.wenzelspine.com

Follow Wenzel Spine on LinkedIn: https://www.linkedin.com/company/wenzel-spine
Follow Wenzel Spine on Twitter: https://twitter.com/WenzelSpine
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Follow Wenzel Spine on Instagram: https://Instagram.com/wenzelspine

View source version on businesswire.com: http://www.businesswire.com/news/home/20170222005421/en/

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Stryker only needs state approval for Portage brownfield plan

Posted On February 22, 2017 By OrthoSpineNews In Financial /  

By Malachi Barrett –  February 22, 2017

KALAMAZOO, MI — One final step remains to approve a brownfield plan for a $150 million Styker Instruments project in Portage.

The Kalamazoo County Board of Commissioners became the last local body to sign off on a County Brownfield Redevelopment Authority financing plan that allows Stryker to capture tax revenue to clean up and develop a 288-acre site. Commissioners voted unanimously to approve the plan during its Feb. 21 meeting, which now goes to the state, who has the final say.

Brent Lalomia, vice president of quality and facilities, told the authority Thursday that the proposal for Stryker’s medical instruments division involves 485,000 square feet of facilities that will include three-stories of office space for sales, marketing and support functions connected to a two-story research and development lab. An atrium in the middle will house a customer experience center and functioning showroom.

Lalomia thanked the county brownfield authority for making the process efficient and collaborative.

The development is projected to retain 966 jobs and create an additional 105, a component of the plan lauded by Portage City Manager Larry Shaffer.

 

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Active Implants Appoints Ted Davis President and Chief Executive Officer

Posted On February 22, 2017 By OrthoSpineNews In Extremities /  

February 22, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced that Ted Davis has been appointed president and chief executive officer. Davis succeeds Henry Klyce, who will continue as chairman of the board.

A current member of the Active Implants board, Davis has 25 years of experience in the life sciences industry as an investor and senior executive, including chief executive officer of MicroPort Orthopedics and president of its predecessor Wright Medical Technology’s global OrthoRecon division from 2012 through 2015. Prior to leading the carve out and integration of the OrthoRecon platform, Davis led Wright’s business development, corporate development and research & development functions from 2006 to 2012, with increasing responsibility for the business development, government affairs, national accounts, reimbursement, medical education and global research & development teams. Davis oversaw the acquisition and integration of a series of extremities and biologics platforms during Wright’s transformation into the market leader in the extremities market segment. Prior to joining Wright in 2006, Davis spent 10 years in the life sciences venture capital field, serving on the boards of multiple biotechnology and medical device companies while at MB Venture Partners and Vector Fund Management. He holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree in engineering from Vanderbilt University.

“Ted’s expert business vision, along with his extensive experience providing strategy and leadership at orthopedic companies, makes him an extraordinary fit for Active Implants,” Klyce said. “A proven leader with a track record of delivering results, Ted brings the experience necessary to guide us through our next stage of growth.”

“I am honored and excited to lead Active Implants as we prepare for the next phase of development for the NUsurface Meniscus Implant around the world,” Davis said. “We have an opportunity to fulfill a significant unmet need in the orthopedic market here in the U.S. and worldwide, helping the millions of patients with persistent knee pain following meniscectomy. I look forward to continuing to work with Henry, given his successful track record in the orthopedics and spine medical technology industry and the outstanding progress he has led in the clinical development programs for the NUsurface Meniscus Implant here at Active Implants.”

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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Senators Look to Overhaul Medical Device Inspections

Posted On February 22, 2017 By OrthoSpineNews In Regulatory /  

By Michael Mezher – 21 February 2017

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks to dramatically alter the US Food and Drug Administration’s (FDA) process for inspecting device manufacturers.

Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings.

“The current device facility inspection process lacks transparency, predictability and consistency between facilities,” Isakson said. “This bill is designed to improve communication and consistency in the device facility inspections process, which will allow both FDA and device manufacturers to make more efficient use of resources.”

According to the bill, inconsistencies in how inspections are conducted across FDA’s foreign and domestic offices create challenges for device makers.

“The frequency and nature of inspections of device establishments are not consistently risk-based and a comprehensive, transparent, risk-based approach to inspections would result in greater focus on more significant risks to public health while reducing the burdens on establishments with a strong track record of compliance,” the bill states.

 

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Dallas’ ‘Dr. Death’ gets life in prison over botched surgery

Posted On February 21, 2017 By OrthoSpineNews In Spine /  

FoxNews.com

A Dallas jury sentenced a neurosurgeon dubbed “Dr. Death” by local media to life in prison on Monday, over his role in a botched back surgery that left his elderly patient crippled and in constant pain. Christopher Duntsch, 46, was arrested in July 2015 on five aggravated-assault charges after four of his patients were left crippled and two others died between July 2012 and June 2013, Dallas News reported.  

His trial focused on only one charge of injury to an elderly individual, with victim Mary Efurd testifying that she had trusted Duntsch to perform the 2012 procedure. Efurd, who was then 74, lost a third of her blood and the full use of her legs, Dallas News reported.

“I trusted that he would do what was right,” Efurd said, according to the report.

The 13-day trial included testimony from a doctor who treated Efurd after Duntsch’s procedure and said he found implants placed on muscle instead of bone, and a screw drilled into her spinal cavity.

“It’s as egregious as you can imagine,” Dr. Robert Henderson said, according to Dallas News.  

Jurors heard from other patients, including one who woke from surgery paralyzed from the neck down, another who passes out from chronic pain and a third who talks in a permanent whisper after she was left with a puncture wound in her throat.

 

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American Academy of Orthopaedic Surgeons names Thomas E. Arend, Jr. as new CEO

Posted On February 21, 2017 By OrthoSpineNews In Extremities /  

ROSEMONT, Ill., Feb. 21, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) announced the selection of Thomas E. Arend, Jr., CAE, to the position of Chief Executive Officer, effective April 1, 2017. As CEO, Arend will work directly with the AAOS Board of Directors and executive management team to oversee a staff of 250 and manage an annual budget of $60 million.

“The Academy is very pleased that Tom Arend, an experienced and proven health care leader, will serve as our next CEO,” said AAOS President Gerald R. Williams Jr., MD. “Tom is a strong strategic thinker and visionary leader who understands the complexities of the changing health care arena. He will serve our members and staff well.”

Arend currently serves as Executive Vice President, Chief Operating Officer and General Counsel at the American College of Cardiology (ACC), a 52,000-member organization in Washington, DC. In this role, he is responsible for ensuring the ACC’s overall financial health, operational effectiveness and strategic direction. In addition, he is responsible for all aspects of the College’s legal, risk management and compliance activities.

Since joining the ACC in 2004, Arend has led the College through two CEO transitions and played critical roles in the development of comprehensive relationship with industry standards and code of ethics, as well as the College’s  five-year strategic plan and more recent governance restructuring.  Arend has also spearheaded several successful collaborations with other medical societies and stakeholders that directly benefit the ACC’s mission to transform cardiovascular care and improve heart health. Most recently, he was responsible for the addition of hospital accreditation services to the ACC’s suite of hospital quality improvement offerings.

“I am excited to join the AAOS, and I am honored and humbled to be leading this strong and vibrant organization,” said Arend. “I look forward to advancing the mission of the Academy and working closely with the volunteer leaders, members and staff.”

Prior to joining ACC, Arend served as an attorney at Shaw Pittman, LLP and Jenner & Block. He received a Juris Doctor degree from the Washington College of Law at The American University, a Master of Arts in International Law and Diplomacy from The Fletcher School of Law and Diplomacy at Tufts University, and a Bachelor of Arts from Kenyon College. He is a member of the Maryland and District of Columbia Bar associations, the American Society of Association Executives and the American College of Healthcare Executives.

Arend is replacing AAOS CEO Karen L. Hackett, FACHE, CAE, who is retiring after 14 years at the organization’s helm. The AAOS Board of Directors retained executive search firm Korn Ferry to lead the search for a new CEO.

About the AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.

SOURCE American Academy of Orthopaedic Surgeons

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Stryker Presents First K9s For Warriors Donation At The Honda Classic

Posted On February 21, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /  

MAHWAH, N.J., Feb. 21, 2017 /PRNewswire/ — Stryker Orthopaedics is pleased to announce its second PGA TOUR stop of 2017 with a first-ever appearance at The Honda Classic in Palm Beach Gardens, FL. Throughout the tournament, Stryker will further its commitment to joint health and to the nation’s military through a series of engaging activities for fans and tournament goers. On Thursday, Stryker will host a special K9s For Warriors ceremony, presenting one military hero with a service dog – Stryker’s first official canine sponsorship donation of the year.

As an extension of a successful relationship that began last year, in 2017 Stryker will continue to give a new leash on life to military heroes by sponsoring service canines and empowering veterans to return to civilian life with dignity and independence. Tournament goers can also show their support to veterans by purchasing the same hat that PGA TOUR professionals and longtime brand ambassadors, Fred Funk and Hal Sutton wear on TOUR at the newly renovated Mobility Zone – Stryker’s premiere “joint health” destination. With each hat purchase, Stryker will make a donation to the K9s For Warriors organization.

“This donation is just one of many ways in which we are honored to show our appreciation towards our nation’s veterans,” said Bill Huffnagle, President, Stryker’s Joint Replacement Division. “Stryker is proud to support our military and continue our mission to educate people about joint health and mobility in local communities across the nation.”

In addition to offering hats for sale to benefit K9s For Warriors, fans visiting The Mobility Zone will be able to learn about hip and knee pain and treatment options, as well as participate in fun, health inspired activities. Inside The Mobility Zone, fans can participate in the 2017 Stryker Challenge – a hands-on experience featuring Art H. Ritis, a life-size model that aims to provide tournament goers a basic understanding of joint replacement surgery and Stryker’s products. In addition, fans who stop by The Mobility Zone will be able to enter for a chance to win a trip for two to Atlanta, GA for the TOUR Championship® and walk inside the ropes as an honorary observer – a true VIP experience.1,2

Finally, to further demonstrate its commitment to motivating fans to stay active, Stryker will host the Health Walk at The Honda Classic. The Health Walk highlights joint health facts and tips along the course to educate fans as they follow their favorite golfers.

For a full list of tournaments stops, additional information on the Stryker Challenge as well as K9s For Warriors involvement, please visit: www.StrykerChallenge.com.

  1. Healthcare Professionals (HCPs) are not eligible to enter the Stryker Challenge Sweepstakes or participate in the any of these promotions. HCPs are defined as those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Stryker’s products.
  2. No purchase necessary to enter or win Sweepstakes.  Void where prohibited by law.  For official rules visit StrykerChallenge.com.  Open to legal residents of the US & US Territories, 21+ as of date of entry.  Sweepstakes begins at 12:01 am ET on 1/11/17 and ends at 11:59 pm ET on 8/27/17.  Sponsored by Stryker.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

About PGA TOUR
The PGA TOUR is the world’s premier membership organization for touring professional golfers, co-sanctioning more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR China.

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GS Medical USA Announces New Product Portfolio and Company Enhancements

Posted On February 21, 2017 By OrthoSpineNews In Spine /  

IRVINE, Calif., Feb. 20, 2017 /PRNewswire/ — GS Solutions Inc., DBA GS Medical USA (GSM), a global manufacturer and supplier of spinal implants, instrumentation and developer of high-quality surgical solutions, today announced several influential advancements for the organization. Following a strong close to the 2016 fiscal year, GSM is poised and prepared for an impactful, growth-oriented year in 2017.

“2017 begins anew for GS Medical with the regeneration of our ‘Expanding New Horizons’ concept,” remarks James Shin, CEO. “Our leadership team has worked tirelessly to lay the foundation for a unique infrastructure system which will continue to cultivate and foster new and existing relationships among our distributor colleagues, surgeons, industry contacts, and hospital partners.” Shin further mentions that many customers already engaged with GSM are excited about the direction and progression of the company.

GSM is pleased to announce the confirmed and pending launch of several products to their existing FDA 510k approved product portfolio. GSM currently offers products under the GSS™ and AnyPlus® product lines, and soon plans to launch the AnyPlus® Anterior Cervical Interbody Fusion (ACIF) implant and the AnyPlus® Dual-Lead Pedicle Screw System in March of 2017. This is in addition to the AnyPlus® Direct Lateral Interbody Fusion (DLIF) implant, slated for a Q2 2017 launch. “The company’s research and development team continues to focus on the essential needs of surgeon partners and their patients, thus yielding fundamental product design and manufacturing that fits the bill on a multitude of levels,” explains Shin. “The introduction of our comprehensive interbody line into the marketplace provides surgeons the option to select the appropriate implant that corresponds with the clinical indications of each individual patient,” states Chris Estuesta, Operations Manager at GSM.

With increased demand for the GS products, the company is also actively seeking distributor partnership opportunities. “Our sales team and industry partners are the lifeline of our company,” explains Adam Lampart, Director of US Sales. “We are always looking for qualified partners who desire to work with a company that is end-user focused, and delivers solid products with timely customer service.” For more information about distributor partner opportunities, please contact sales@gsmedicalusa.com.

About GS Medical USA
GS Medical features many spinal products spanning lumbar, thoracic and cervical applications. GSM products have been used in thousands of spine surgeries throughout the USA, and hundreds of thousands globally. Staffed with a network of industry leaders, medical sales distributors, accomplished engineers, and collaborating physicians, GSM is at the forefront of high-quality, value-added medical technology with a number of innovative implant solutions in the commercialization pipeline. Corporate headquarters are in Irvine, California and with international offices located in Seoul, Korea.

Media Relations Contact:
Amanda Collins
146989@email4pr.com
Phone: 831.477.1307 x213
FAX: 866.600.9712
6 Wrigley
Irvine, CA 92618

www.gsmedicalusa.com

SOURCE GS Medical USA

Related Links

http://www.gsmedicalusa.com

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Experts weigh in on the state of medical device security today and beyond

Posted On February 21, 2017 By OrthoSpineNews In Regulatory /  

By for Zero Day – February 21, 2017

The heat is on medical device vendors, healthcare providers, and security firms to tackle the emerging problem of cyberattacks focused on the Internet of Medical Things (IoMT).

Hardly a week goes by when we don’t hear of the latest company to fall victim to hackers, but the ability to compromise medical devices may go far beyond the consequences of standard malware infections and the theft of personally identifiable information (PII).

Attacks against medical devices can occur due to social engineering and network infiltration, as well as vulnerabilities in hardware and software. The most common threats today include ransomware, man-in-the-middle (MiTM) attacks, phishing and, on occasion, physically compromising devices.

Strong networks can create a barrier between attackers and healthcare systems, but medical devices can suffer from the same vulnerabilities, exploits, outdated firmware and security flaws that plague traditional computer systems.

Medical device security hit the spotlight in 2012 when IOActive security researcher Barnaby Jack discovered transmitter security flaws which could be used to deliver lethal shocks to pacemakers. Recently, medical equipment maker St. Jude Medical was forced to patch security holes in the firm’s cardiac devices.

While medical devices may be targeted for the purposes of causing harm to individual patients or blackmail, one of the main reasons appears to be for financial gain.

In March 2016, US hospital chain MedStar’s IT infrastructure was crippled after a successful malware attack, and California’s Hollywood Presbyterian Medical Center paid attackers thousands of dollars after ransomware disrupted critical services in the same year.

Speaking to ZDNet, Jason Allaway, vice president of RES UK & Ireland, said the main threat to hospitals is ransomware due to the “devastatingly effectiveness” of attacks — and “because the consequence of losing data goes far beyond a financial cost.”

“Unlike data held by other organizations, such as those operating in finance, medical data holds a life or death value,” Allaway says. “Medical organizations can’t even give out the most basic of painkillers if their data is not fully available. […] Unless hospitals have a stringent backup policy, there is little option other than paying a ransom so that staff can continue to provide critical medical care.”

 

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TransEnterix Schedules Fourth Quarter and Fiscal Year 2016 Financial and Operating Results Conference Call for March 6, 2017

Posted On February 21, 2017 By OrthoSpineNews In Financial /  

February 21, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT: TRXC) announced today that it plans to release fourth quarter and fiscal year 2016 financial and operating results after the market closes on Monday, March 6, 2017. Todd M. Pope, President and Chief Executive Officer and Joseph P. Slattery, Executive Vice President and Chief Financial Officer will host a conference call to discuss these results starting at 4:30 pm Eastern Time the same day. The call will be concurrently webcast.

To listen to the conference call on your telephone, please dial, 888-724-9516 for domestic callers and 913-312-0978 for international callers, and reference TransEnterix Call approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

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. 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 has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
Or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
(For US) Hannah Dunning, +1 415-618-8750
TransEnterix-SVC@sardverb.com

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