Johnson & Johnson’s Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial. The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures. Dr. Dr. Mattias Duytschaever performed […]
Catheters
Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
Field Medical announced today that it closed an oversubscribed seed round with investments reaching $14 million. Private investors led the funding for the Cardiff-by-the-Sea, California-based cardiac ablation technology developer. Multiple strategic investors also joined the round. The company earmarked the funds to support preclinical-to-clinical development activities. That includes first-in-human studies slated to begin in early […]
Shockwave picks Abbott Vascular exec Dr. Nick West as next chief medical officer
Shockwave Medical announced today that it appointed Dr. Nick West as its new associate chief medical officer. West’s appointment marks the start of an eventual transition. He reports to the current CMO, Dr. Keith Dawkins, with intentions to succeed Dawkins in mid-2024. “Dr. West brings to Shockwave a wealth of expertise in the interventional cardiology […]
Gradient Denervation raises $15M Series A for catheter tech
Gradient Denervation Technologies announced that it closed a $15 million (€14 million) Series A financing round. Paris-based Gradient develops a catheter-based solution for treating pulmonary hypertension. It expects the financing to support the ongoing clinical development and evaluation of the ultrasound-based device. Asabys Partners led the round through its new fund, Sabadell Asabys II. Thuja […]
Cordis names former Spectranetics CEO as executive chair
Interventional vascular tech company Cordis today announced that board member Scott Drake will be the new executive chair of its board of directors. Drake succeeds Duke Rohlen, who served as executive chair since Hellman & Friedman and KKR acquired the company from Cardinal Health in 2021. Rohlen will stay on the company’s board of directors […]
Synchron completes patient enrollment in brain-computer interface trial
Synchron announced today that it completed patient enrollment in the COMMAND clinical trial for its brain-computer interface (BCI). The U.S.-based trial operating under FDA investigational device exemption (IDE) enrolled six patients in total. Synchron says it’s the first IDE awarded by the FDA to assess a permanently implanted BCI. The early feasibility study assesses safety […]
Medtronic stock is down on new RDN system setback
Medtronic stock is taking a hit after an FDA review panel found the risks of its renal denervation system outweighed the benefits. The world’s largest medical device company engaged in more than a decade of clinical trials and research — with multiple disappointments along the way — as it made a bet that its radiofrequency-energy-based […]
FDA fast-tracks aneurysm stabilization system from Nectero Medical
Nectero Medical announced today that the FDA granted fast track designation to its endovascular aneurysm stabilization treatment (EAST) system. Tempe, Arizona–based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a randomized, controlled Phase […]
ReCor Medical wins FDA panel nod for its renal denervation system
ReCor Medical announced that an FDA panel has voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. On Aug. 22, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 12–0 in favor with regard to safety and 8–3 in favor, with […]
FDA review panel: Medtronic Symplicity Spyral RDN risks outweigh benefits
An FDA review panel voted against recommending approval of Medtronic’s Symplicity Spyral renal denervation (RDN) therapy for hypertension under the proposed indications. The panel unanimously said the minimally invasive catheter system is safe, but was nearly split on efficacy. With six members voting that the benefits outweighed the risk, six voting the other way and […]
Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon trial. The first-in-human trial evaluates initial short-term […]
