The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA). Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a […]
Implants
Conformis, Stryker settle in Wright Medical patent infringement litigation
Conformis (NSDQ:CFMS) announced today that it settled with Stryker (NYSE:SYK) to resolve patent litigation involving Wright Medical. Billerica, Mass.based Conformis said in a news release and SEC filing that Stryker — which acquired Wright Medical in November 2020 — will make a one-time $15 million payment to Conformis. Stryker in return will receive a non-exclusive license […]
Orthofix announces U.S. launch, first patient implant of 3D-printed spacer system
Orthofix (NSDQ:OFIX) announced today that it launched and implanted the first 3D-printed Forza Ti PLIF spacer system in the U.S. Lewisville, Texas-based Orthofix’s 3D-printed Forza Ti posterior lumbar interbody fusion (PLIF) spacer system uses the company’s Nanovate technology to comprise a titanium lumbar interbody device that allows the bone to grow into and through the […]
Axonics files FDA PMA supplement for its non-rechargeable SNM system
Axonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system. Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release. The company designed its new non-rechargeable SNM system to replicate the key features of […]
Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant
Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface. Get the full story on our sister […]
Glaukos wins Australian regulatory approval for MicroShunt
Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia’s Therapeutic Goods Administration for its Preserflo MicroShunt. The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or where glaucoma progression needs surgery. Get the full story on our […]
Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant. San Clemente, Calif.–based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for […]
FDA approves Medtronic’s SenSight directional lead system for DBS therapy
Medtronic (NYSE:MDT) announced today that it received FDA approval for its SenSight directional lead system used in deep brain stimulation therapy. Fridley, Minn.–based Medtronic designed the SenSight directional lead system for DBS therapy to combine directionality and sensing to allow physicians to deliver precise, patient-specific DBS therapy for treating some symptoms associated with movement disorders […]
Philips touts 2-year data for Tack endovascular system
Royal Philips (NYSE:PHG) today announced positive two-year results from a clinical trial of the Tack endovascular system. Amsterdam-based Philips presented data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial at the 2021 New Cardiovascular Horizons Conference, according to a news release. Data presented by co-principal investigator Dr. George Adams, an interventional […]
FDA clears ChoiceSpine’s Blackhawk Ti cervical spacer system
ChoiceSpine announced today that it received FDA clearance for its Blackhawk Ti cervical spacer system. Knoxville, Tenn.-based ChoiceSpine designed its Blackhawk Ti cervical spacer system with the BioBond 3D-printed titanium porous matrix and a large open graft window for bone graft containment and maximum visualization, according to a news release. Additionally, the platform consists of […]
Feds want more input on materials with ‘high-profile safety concerns’
The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]