1. InspireMD inks Taiwanese distro deal for CGuard
InspireMD announced in a June 8 press release that it has signed a distribution deal with Lorion Enterprises. The deal will expand InspireMD’s global footprint and distribute its CGuard Embolic Prevention System (EPS) through the medical device distributor in Taiwan.
2. Active Implants launches NUsurface knee trial
Active Implants announced that it has started its Safety Using NUsurface (SUN) trial in San Diego, according to a June 7 press release. The purpose of the clinical trial is to test the NUsurface Meniscus Implant that is designed to treat persistent knee pain from injured or deteriorating meniscus cartilage. The SUN study will enroll about 120 patients to gain approval from the FDA to be able to sell the device in the U.S.
3. Medtronic and Acacia bury the hatchet
Acacia Research Corp. announced in a June 6 press release that it has entered a license agreement with Medtronic and Medtronic Vascular that covers patents for surgical devices. The license agreement resolves a pending litigation in the U.S. District Court for the District of Delaware.
4. Exactech successfully implants ExactechGPS shoulder repair devices for the first time
Exactech announced that its Equinoxe Preserve stem conservative shoulder treatment option was successfully implanted for the first time, according to a June 6 press release. The shoulder treatment is designed to preserve humeral bone in shoulder replacement surgery. It was designed through CT reconstruction data and clinical studies and features a polished distal tip, a straight lateral fin for greater rotational stability and plasma coating for proximal fixation. The Preserve Stem and ExactechGPS Shoulder Application is expected to have a full U.S. market availability in the beginning of 2018.
5. FDA expands clearance for 3M’s Tegaderm dressing
3M announced in a June 6 press release that the FDA expanded its 510(k) clearance for 3M’s Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing. The expansion includes the dressing’s abilities to reduce catheter-related bloodstream infections (CRBSI). A randomized, multi-arm, controlled clinical trial of 1,879 patients showed that the dressing reduced CRBSI by 60% in patients with central and arterial lines. The clinical trial helped expand the 510(k) clearance.
6. HLT enrolls 1st patients in Meridian TAVR feasibility study
HLT has announced the first U.S. patient implants for a clinical trial of the Meridian Transcatheter Aortic Valve and Pathfinder II Delivery System, according to a June 6 press release. The clinical trial is designed to study the safety and performance outcomes of the delivery system in patients who have severe aortic stenosis and are at a high-risk for surgery. The study will enroll 20 high-risk patients with severe aortic valve stenosis and evaluate all-cause mortality at 30 days. There will be a follow up at 1, 6 and 12 months within the 1st year and annually for the next 5 years.
7. Advanced Cooling Therapy rebrands as Attune Medical
Advanced Cooling Therapy announced in a June 6 press release that it is the corporate name to Attune Medical. The company said that the name change will better represent the company’s commitment to temperature management therapy in clinical contexts.