Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system. Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. In addition, it features a low-profile frame for avoiding obstruction of the left ventricular outflow tract […]
Implants
Synchron says study shows safety of its brain-computer interface implant
Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input. New York-based Synchron said this study demonstrated the safety of its brain-computer […]
CartiHeal wins FDA premarket approval for its Agili-C knee implant
CartiHeal announced today that it received FDA premarket approval for its Agili-C implant for treating knee joint surface lesions. Kfar Saba, Israel-based CartiHeal designed its Agili-C implant as a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints. Its PMA indication covers the treatment of an International Cartilage Repair Society (ICRS) grade III […]
FDA clears Ossio’s OssioFiber suture anchors for bone fixation
Ossio announced today that it received the third FDA clearance for its OssioFiber product family in recent months. Woburn, Massachusetts-based Ossio’s latest regulatory nod covers the OssioFiber suture anchors (4.75 mm-5.5 mm) for use in the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in a variety of […]
Staar Surgical wins FDA approval for Evo Visian implantable Collamer lens
Staar Surgical (Nasdaq:STAA) announced today that it received FDA approval for its Evo/Evo+ Visian implantable Collamer lens. Lake Forest, California-based Staar Surgical designed the Evo biocompatible implantable lens for the correction of myopia and myopia with astigmatism. More than 1 million Evo lenses have been implanted by doctors outside the U.S., according to a news […]
Medtronic completes first patient implants in implantable tibial neuromodulation trial
Medtronic (NYSE:MDT) announced that it completed the first patient implants in the Titan 2 pivotal study of its investigational neuromodulation device. Fridley, Minnesota-based Medtronic’s Titan 2 trial will evaluate the safety and efficacy of the company’s implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB). The company designed the minimally invasive implantable TNM […]
FDA approves two clinical trials for HLT’s TAVR system
HLT announced today that it received FDA approval for two clinical studies for its HLT Meridian transcatheter aortic valve replacement (TAVR) system. Maple Grove, Minnesota-based HLT, a Bracco Group Company, will conduct the studies to assess the performance of the HLT Meridian TAVR system in treating aortic stenosis and aortic regurgitation among high-risk patients suffering […]
Stryker launches new hip stem that’s compatible with the Mako robot-assisted surgery system
Stryker (NYSE:SYK) announced today that it launched the Insignia hip stem for total hip and hemiarthroplasty procedures. Presenting at the American Academy of Orthopaedic Surgeons (AAOS) 2022 Annual Meeting in Chicago, Stryker introduced the Insignia hip stem for optimizing patient fit and surgeon ease of implantation in muscle-sparing approaches for total hip and hemiarthroplasty procedures. Insignia […]
PAVmed completes first-in-human implantations of its intraosseous infusion system
PAVmed (Nasdaq:PAVM) announced today that it successfully completed the first human implants of its PortIO intraosseous infusion system. New York-based PAVmed designed its PortIO system with an implantable intraosseous vascular access device and insertion kit. Instead of a catheter located in a vein, the system has a short extension from the device inserted by a physician […]
DeviceTalks Boston returns with a unique approach for medtech connections and development
A few months back, I wrote what was best described by a colleague as a “salty” Medical Design & Outsourcing column in which I demanded conference organizers like myself step up our game if we expect to bring back attendees. “For too long, conference organizers have relied upon a potent cocktail of FOMO and habit,” […]
FDA clears Axonics’ recharge-free sacral neuromodulation system
Axonics Modulation Technologies (Nasdaq:AXNX) announced today that it received FDA approval for its new implantable neurostimulator. Irvine, California–based Axonics designed the Axonics F15 recharge-free sacral-neuromodulation (SNM) system with a functional life span of over 15 years at typical stimulation parameters and more than 2 decades at lower-energy settings. The system’s size totals 10 cubic centimeters, […]