Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke. The company also picked up clearance under the MDSAP program, giving broad access to international markets. Authorization covers the majority of the company's products, including: HiPoint 70/Tenzing 7 … [Read more...] about Route 92 Medical picks up CE mark for stroke portfolio
Catheters
EndoTheia completes first-in-human study of steerable kidney stone basket
EndoTheia announced today that it completed the first-in-human clinical trial for its FlexStone basket, a steerable kidney stone treatment. Nashville, Tennessee-based EndoTheia said its FlexStone basket represents the first-ever independently steerable kidney stone basket. It enables precision and control in kidney stone removal by letting … [Read more...] about EndoTheia completes first-in-human study of steerable kidney stone basket
JenaValve to begin Trilogy heart valve trial
JenaValve announced today that it received the green light to begin a new randomized controlled trial for its Trilogy device. Irvine, California-based JenaValve can now start the ARTIST trial, slated for early next year. The company — set to be acquired by Edwards as part of a $1.2 billion double M&A swoop alongside Endotronix — also … [Read more...] about JenaValve to begin Trilogy heart valve trial
Endologix reports positive 3-year Detour PAD treatment data
Endologix announced the final 36-month results for the DETOUR2 study evaluating its Detour system for treating peripheral arterial disease (PAD). Detour features the EndoCross device and Torus stent grafts. It enables physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein. This restores … [Read more...] about Endologix reports positive 3-year Detour PAD treatment data
Penumbra has positive data for computer-assisted vacuum thrombectomy system
Penumbra (NYSE:PEN) today announced new data demonstrating improved outcomes with its computer-assisted vacuum thrombectomy (CAVT) technology. Data evaluated the use of the CAVT technology in people with intermediate-risk pulmonary embolism (PE). Results showed that those treated with CAVT had shorter hospital stay lengths, shorter … [Read more...] about Penumbra has positive data for computer-assisted vacuum thrombectomy system
Shockwave Medical’s Javelin IVL catheter meets primary trial endpoints
Johnson & Johnson MedTech's Shockwave Medical unit today announced the first clinical outcomes associated with its Javelin catheter. Shockwave shared the first clinical outcomes associated with its Javelin peripheral intravascular lithotripsy (IVL) catheter system. It designed this novel, non-balloon-based lithotripsy platform to modify … [Read more...] about Shockwave Medical’s Javelin IVL catheter meets primary trial endpoints
FDA approves IDE for Akura Medical’s thrombectomy system
Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE). IDE means Akura can begin the QUADRA-PE study evaluating the thrombectomy system in patients with acute pulmonary embolism (PE). Dr. Sanjum Sethi (Columbia University Medical Center) and Dr. Ann Gage … [Read more...] about FDA approves IDE for Akura Medical’s thrombectomy system
Boston Scientific to acquire Cortex and its cardiac mapping tech
Boston Scientific (NYSE: BSX) announced today that it will purchase Ajax Health's Cortex and its FDA-cleared OptiMap system to guide physicians performing ablation procedures to treat AFib Financial terms of the deal were not disclosed. Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing … [Read more...] about Boston Scientific to acquire Cortex and its cardiac mapping tech
Merit Medical completes acquisition of Cook Medical’s lead management portfolio
Merit Medical Systems (Nasdaq:MMSI) announced today that it completed its acquisition of Cook Medical’s lead management portfolio. South Jordan, Utah-based Merit announced its agreement to buy the portfolio for $210 million in September. Merit funded the acquisition through a combination of cash on hand and borrowings under a long-term credit … [Read more...] about Merit Medical completes acquisition of Cook Medical’s lead management portfolio
Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson MedTech today announced the completed enrollment of the pilot phase of a clinical trial for its Omnypulse platform. The OMNY-AF clinical trial evaluates the investigational platform for the treatment of symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase … [Read more...] about Johnson & Johnson completes pilot enrollment in Omnypulse trial
