Solvay Advanced Polymers LLC and Secant Medical LLC have forged a marketing partnership to promote the development and production of implantable biomedical fabric structures made of Zeniva PEEK (polyetheretherketone) fiber.
“Our collaboration will expand Secant Medical’s offering, broaden our ability to help clients to innovate their concepts, and further expand our leadership position in biomedical textiles engineering,” said Karen West, vice president of advanced technologies for Perkasie, Pa.-based Secant Medical.
This collaboration, which also includes an undisclosed fiber manufacturer, marks the formation of a new supply chain: OEMs will have the option to develop custom implantable fabrics made of Zeniva PEEK for therapeutic devices in orthopedics, cardiovascular, tissue engineering, neurology and general surgery.
“This partnership further solidifies our position as a strategic material supplier in the healthcare industry,” said Shawn Shorrock, global healthcare market manager for Brussels, Belgium-based Solvay Advanced Polymers. “This new material solution is being offered in direct response to our customer demands and meets their strict performance requirements.”
ArthroCare Gets FDA Clearancefor Suture Implant
ArthroCare Corp. has received 510(k) clearance for its Spartan 6.5 Needled Anchor, a reloaded threaded anchor designed for mending soft tissue to bone, such as during a rotator cuff repair procedure. This version is ideal for open repairs, whereas the non-needled version, for which U.S. Food and Drug Administration (FDA) clearance previously has been received, is for arthroscopic repairs.
The Spartan anchor is part of the company’s line of anchors that can be used with suture passing technology, such as the FirstPass suture passer. It features a 6.5 millimeter screw-in design and can be used to perform single and double row repairs. The Spartan anchor is manufactured from PEEK (polyetheretherketone).
ArthroCare is based in Austin, Texas.
InVivo Announces Patent Expansion
InVivo Therapeutics Holding Corp. has expanded the “Field of Use” of its existing patent license to include parts of the peripheral nervous system, the cavernous nerve surrounding the prostate, the brain, the retina and cranial nerves. InVivo has a worldwide license to a broad suite of patents co-owned by the Massachusetts Institute of Technology and Children’s Hospital Boston (the CMCC License).
The CMCC License previously covered a wide range of biopolymers to treat spinal cord injury and to promote the survival of spinal cord cells. It includes 10 issued U.S. patents and three pending U.S. patents, as well as 67 international rights and 34 pending international copyrights. InVivo will leverage its experience in spinal cord injury to create new treatment options for peripheral nerve injuries, epidural injections, cavernous nerve repair following prostate surgery, retina repair, spinal cord tumors and applications in the brain.
“The patent expansion will allow InVivo to not only develop treatments for unmet medical needs but also to add potential revenue streams,” said Frank Reynolds, CEO of Cambridge, Mass.-based InVivo Therapeutics.
Evonik to Distribute Through Modern Plastics in North America
Evonik Degussa Corporation announced that Modern Plastics Inc. will distribute Vestakeep Medical PEEK (polyetheretherketone) in the United States and Canada.
“We value our relationship with Modern Plastics, the distributor of medical-grade plastics, and are excited about utilizing their experience and expertise,” said Kenneth Ross, business development manager for Parsippany, N.J.-based Evonik.
The agreement covers Vestakeep medical products, including implant grade powder, implant grade resin, multiple diameter stock shapes (one and three meter lengths among others), and resin lines (5 kilogram and 10 kilogram containers).
“The value proposition we now offer is exciting and our medical OEM customers have easier access to Vestakeep PEEK,” said Bing J. Carbone, president of Shelton, Conn.-headquartered Modern Plastics.
Fort Wayne Metals GetsTrademark for Microstructural Refinement Process
Fort Wayne Metals Research Products Corporation has obtained trademark registration for the NDR (Nanograin Damage Resistant) process. The company’s NDR is patent pending. NDRdenotes a thermal-mechanical process designed to produce nanoscale microstructural refinement, evidenced by a significant increase in the material’s ability to resist damage during high cycle mechanical loading, such as during service of a long-term cardioverter defibrillator lead implant.
“While our results may not translate into every application, we have observed improvements in the rotary beam fatigue strength of up to 83 percent in 0.007-inch diameter ASTM F562 wire during our testing,” said Jeremy Schaffer, senior research and development engineer. “By leveraging microstructural mechanisms through significant refinement of the grain size in NDR wire, we can increase fatigue strength without changing the chemical makeup of the alloy. And we can do it without significant impact to other wire properties like corrosion resistance.”
The process can be applied to non-precipitation hardening, non-sensitizing, implant-grade alloys.
Fort Wayne Metals is located in Fort Wayne, Ind.
DJO Global Debuts Shoulder System DJO Global Inc. has introduced the Turon Modular Shoulder System, a system that incorporates the company’s proprietary IMIN (Intrinsic Modular Indexable Neck) technology. IMIN contains a clocking feature that allows the humeral neck shaft angle position to be dialed in, enablingsurgeons to custom fit patients’ anatomies without adjunctive screw fixation, complex jigs and back table fixtures.
“We are excited about our new Turon modular shoulder,” said Mike Mogul, CEO of DJO Global. “The addition of Turon along with our Reverse Shoulder Prosthesis demonstrates our leadership and commitment to move orthopedic technology forward in shoulder replacement surgery.”
The Turon system was developed by the company’s surgical division. DJO Global is headquartered in San Diego, Calif.
Wenzel Spine Reaches Milestone Mark for Implants
Wenzel Spine Inc. has surpassed 26,000 successful implantations of its Stand-Alone VariLift Expandable Interbody Fusion Device.
“We are pleased to reach this significant milestone,” said Chad Neely, CEO of the Austin, Texas-based company. “VariLift has experienced tremendous success worldwide and we look forward to achieving the same success in the U.S. as we begin our full market release with the 2011 launch of VariLift.”
The VariLift System provides a minimally invasive, stand-alone solution for interbody fusion procedures. The technology is used in single or two contiguous levels in the lumbar spine (L2-S1) for treatment of degenerative disc disease and related instability. It is approved by the U.S. Food and Drug Administration (FDA) for posterior, transforaminal, and anterior lumbar interbody fusion applications and without supplemental fixation.
“VariLift is an exciting option for spine surgeons performing lumbar fusion surgery as it creates immediate stability and fixation by expanding in-situ once it’s properly positioned,” said Daniel Peterson, M.D., clinical adjunct professor of biomedical engineering at the University of Texas in Austin.
The system received CE Mark approval in November 2010, along with VariLift-C, a cervical device design and application. It currently is the only FDA-cleared, stand-alone interbody fusion device that expands in-situ, without pedicle screws and rods, providing a minimally invasive alternative to traditional spinal fusion.
SpinalCyte Receives U.S. Patent for Spinal Disc Tissue Engineering
Houston, Texas-based SpinalCyte LLC, a spinal technology company focused on autologous regrowth of the spinal disc nucleus using human dermal fibroblasts, received patent No. 7,850,983 from the U.S. Patent Office—“Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor” to regrow the spinal disc, using human dermal fibroblasts.
The allowed claims include the use of human dermal fibroblasts from the patient’s own body, to regrow the nucleus of the spinal disc in vivo. SpinalCyte has simulated the environment of the spinal disc.
Using intermittent hydrostatic pressure, the dermal cells have successfully differentiated into cartilage type cells necessary to regrow the nucleus pulposus, according to the company.
The nucleus pulposus is a gelatinous material that acts as a cushion to the spinal column. It functions to distribute hydraulic pressure in all directions within each disc under compressive loads. The nucleus pulposus consists ofchondrocytes, collagenfibrils, and proteoglycanaggrecans.
“This milestone is a major achievement and strengthens our position in this emerging technology,” said Pete O’Heeron, CEO. “We are excited about the future for this type of technology and the benefit it will ultimately bring the patient by regrowing their disc, using their own cells.”
Nucleus replacement is a growing field in the spinal surgery arena.
SpinalCyte was founded in 2007. The firm’s goal, according to its leadership, is to develop a nucleus regrowth technology using autologous dermal cells harvested from the patient. To date, SpinalCyte has been funded entirely by angel investors.
Ascension Orthopedics DebutsMini Glenoid
Ascension Orthopedics Inc. has announced the market release of the Titan Inset Mini Glenoid, an addition to the Titan Modular Shoulder System for glenoid arthritis.
“We are striving to continually release innovative products into the market place,” said Guy Mayer, president and CEO of Austin, Texas-based Ascension Orthopedics. “We are excited to build on the clinical success of the Titan shoulder line with another addition.”
The Mini Glenoid is available in round and oval designs, allows for less instrumentation in the operating room, and can be used in humeral resurfacing arthroplasty, hemi or total shoulder arthroplasty and press-fit or cemented fracture arthroplasty. In addition, the ease of reproducibility allows for more consistent patient outcomes, according to the company.
“The Mini Glenoid prosthesis is designed to resurface the central portion of the glenoid as well as load-share with the peripheral glenoid bone, which allows for minimal forces to be transmitted on the edge of the Mini Glenoid prosthesis,” commented Mark Ross, M.B., B.S., F.R.A.C.S., F.A. (ORTHO) A. “These edge forces have been shown to lead to loosening in a standard glenoid.”
New Knee Product Cleared for OMNIlife Science
OMNIlife science Inc. received U.S. Food and Drug Administration clearance for its Apex Posterior Stabilized (PS) Knee, the latest addition to the Apex product family. The design, which has positively been received by the European market since its 2010 debut, is expected to make its U.S. launch by the end of 2011.
“We believe that the design of the Apex PS Knee will set a new standard in the orthopedic industry that will benefit both patients and surgeons,” said George Cipolletti, CEO of OMNIlife science Inc. and Orthopaedic Synergy Inc.
The new design offers a post and cam system while sustaining key design elements of the existing Apex Cruciate Retaining (CR) Knee. It also allows up to an additional 30 degrees of uninterrupted patella track, which potentially reduces the chances of patella “clunk,” according to the company. In addition, a single step reaming process allows an intraoperative transition from a CR Knee to a PS Knee based on surgeon preference. Finally, the intercondylar fossa for the location of the Apex PS Knee “box” cut allows for as much as a 90 percent reduction in the bone removed compared to some competitive PS knee designs.
“I enjoy using the instruments for the Apex PS knee; it’s certainly the easiest and most repeatable box cut that I have ever made,” said Anthony F. Infante, Jr., D.O., of the Florida Orthopaedic Institute. “In the past, I’ve typically used an ultra congruent insert for posterior stabilization because of the amount of bone that was removed in a typical PS Knee. With the OMNI system, the amount of additional bone that is removed is so insignificant I have no problem using this PS Knee in all my patients.”
OMNIlife science is based in East Taunton, Mass., and is a subsidiary of Raynham, Mass.-headquartered Orthopaedic Synergy Inc., a holding company for businesses that develop orthopedic products.
Bonovo Launches New Division for China Objectives
Bonovo Orthopedics Inc. has formed a new division, Bonovo Recon, that is dedicated to accelerating the growth of hip and knee product development and sales initiatives. The new division kicks off operations with a full line of hip and knee products for sale in the Chinese orthopedic market.
“Bonovo has developed one of the most comprehensive total joint design and development teams in China, along with a full pipeline of products,” said Peter Slate, CEO. “The formation of Bonovo Recon provides Bonovo with a more focused platform to continue making investments in this market.”
Scottsdale, Ariz.-based Bonovo first acted on its interest in the Asian market in 2007, when it acquired
Tianjin, China-based Kangknow, Inc., a maker of hip products. The following year, Bonovo entered into a partnership with Osaka, Japan-based Japan Medical Materials Corporation to develop a ceramic bi-surface knee system designed specifically for the Asian anatomy and lifestyle with improved knee flexion and durability, the first to be introduced in China.
The new division has dedicated hip and knee sales teams; Bonovo also is increasing its joint reconstruction training efforts through the Bonovo Academic Alliance, its organization dedicated to training and enhancing the connection between Eastern and Western surgeons.
“The formation of Bonovo Recon solidifies Bonovo’s commitment to provide customers throughout China with a complete portfolio of hip and knee products and a team committed to training and personal service,” said Chip Bao, president of Bonovo Asia. “Through Bonovo Recon, we will continue to play a role in improving patient care in the Chinese orthopedic market.”
Bonovo’s China office is in Beijing.
Altor acquires Orchid Orthopedic Solutions
Orchid Orthopedic Solutions has a new private owner.
The worldwide design and manufacturing services supplier of orthopedic and dental implants and instruments has been purchased by Altor Fund III from Churchill Equity Inc. Altor is a Swedish private equity firm that invests in and develops medium-sized companies in Europe's Nordic region.
“We are delighted to have Altor as a new owner,” Orchid CEO Mike Miller said. “Altor shares our view on the future development of the company and has the resources, experience, and time horizon required.”
Altor executives said they based their decision to acquire Orchid on the orthopedic industry’s prospects for long-term growth.
Though Altor officials did not reveal a purchase price for Orchid or an overall growth strategy for the company, they hinted that future growth could come from a combination of organic development and international expansion.
“We are impressed with Orchid’s performance and its management team, and we are excited about the opportunity to develop and support the company,” said Hans Stråberg, an Altor board member and former CEO of Electrolux.
Churchill Equity executives called Altor a “perfect match” for Orchid.“We are very pleased to have found a dynamic, committed and resourceful new owner for Orchid. Altor, with its international experience, resources and ability to take a longer term investment perspective, is the perfect match for Orchid,” said Sameer Vijayakar, a partner at Churchill Equity, a Minneapolis, Minn.-based provider of equity investment capital.
Orchid provides design and development, implant and instrument manufacturing, advanced machining, plastics technology, implant coatings and surface treatment, and packaging services. The company is based in Holt, Mich.