Exactech (NSDQ:EXAC) revealed results from 10 new studies that the company said highlighted the benefit of its knee and shoulder implants. Two knee-related studies focused on results from Exactech’s Truliant total knee arthroplasty cases and postoperative outcomes with the Optetrak Logic knee system for both men and women. Two further studies centered around the Equinoxe for […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Sientra posts Q3 losses, acquires Opus breast implant operation
Sientra (NSDQ:SIEN) shares skyrocketed today after the company posted Street-beating third-quarter results despite a bottom-line dip. The Santa Barbara, Calif.-based company is also acquiring the Opus breast implant manufacturing operation. Sientra posted losses of -$22.43 million, or -45¢ per share, on sales of $22.41 for the three months ended Sept. 30, for a 9.2% bottom-line slide […]
Conformis launches next-generation hip system
Conformis (NSDQ:CFMS) has won FDA clearance for its latest 3D-designed Conformis hip system for hip surgeries. The Billerica, Mass.–based company began hip surgeries in July 2018 during a limited launch of its hip system. The latest version of the system, announced yesterday, incorporates design improvements based on surgeon feedback after more than 400 surgeries were completed […]
OsteoRemedies launches Remedy knee spacer with modular stems
OsteoRemedies said today that it initiated the full commercial launch of its Remedy knee spacer with attachable modular stems for connecting the femoral and tibial component. The Remedy knee spacer is designed for use in a two-stage procedure in the event of permanent prosthesis infection. It is intended for temporary use in 180 days or […]
Spineology touts outcome of U.S. clinical trial for interbody fusion
Spineology announced that 24-month outcomes from its Scout clinical trial for interbody fusion revealed substantial improvements in scores for low back pain and functional limitations. The Scout trial was conducted under an FDA-approved investigational device exemption protocol to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for treating degenerative disc disease. Spineology […]
FDA clears DiFusion’s spinal implant with new biomaterial
DiFusion said today that it won FDA 510(k) clearance for its Xiphos-ZF spinal interbody device, the first spinal implant developed from the biomaterial Zfuze. Zfuze is a new biomaterial that is said to elicit pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. Both IL1-Beta and IL6 are cytokine markers for prolonged […]
FDA clears Stryker’s Sahara expandable interbody implant
Stryker (NYSE:SYK) said yesterday that it won FDA 510(k) clearance for its Sahara lateral 3D expandable interbody implant system. Sahara Lateral is the first ever 3D-printed lateral expandable fusion device, according to a news release. It is designed to allow surgeons up to 30 degrees of sagittal spinal correction in skeletally mature patients. The implant is […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
Hancock Jaffe touts 6-month results for VenoValve
Hancock Jaffe Laboratories (NSDQ:HJLI) said yesterday that six-month data from its in-human VenoValve study showed that the first five patients observed displayed improvements in all study endpoints. Principal investigator Dr. Jorge Hernando Ulloa reported that the patients showed 10% improvement in reflux, 2% improvement in disease manifestations (VCSS scores) and 13% improvements in pain (VAS scores) […]
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