Reflow Medical today announced the enrollment of the first patient in its DEEPER CHALLENGE trial at the Medical University of Graz. The investigator-initiated, single-center, single-arm, prospective study investigates early vessel recoil following below-the-knee treatment using the Spur peripheral retrievable scaffold system in combination with … [Read more...] about Reflow Medical enrolls first patient in retrievable scaffold trial
Catheters
Terumo initiates voluntary thoracic stent graft recall after 3 deaths
Terumo announced today that it initiated a voluntary recall of specific models of its Relay Pro thoracic stent graft system. Affected products include the Relay Pro NBS (non-bare stent) models with diameters ranging from 32 mm to 46 mm. The recall spans approximately 7,000 affected units sold between May 2024 and March 2026. Tokyo-based Terumo … [Read more...] about Terumo initiates voluntary thoracic stent graft recall after 3 deaths
Peytant Solutions announces first human use of tracheobronchial covered stent system
Peytant Solutions today announced the first-in-human implantation of its AMStent tracheobronchial covered stent system. The implantation took place at Fairview East Bank University Hospital (M Health Fairview University of Minnesota Medical Center). Minneapolis-based Peytant said it marked the first clinical use of a stent covered with a … [Read more...] about Peytant Solutions announces first human use of tracheobronchial covered stent system
StarMed wins FDA clearance for RF ablation platform for thyroid nodules
StarMed announced today that it received FDA 510(k) clearance for its platform that delivers radiofrequency (RF) ablation of thyroid nodules. The company said this clearance makes it the first and only one with an FDA indication for RF ablation of thyroid nodules. Until now, according to StarMed, patients requiring thyroid nodule intervention … [Read more...] about StarMed wins FDA clearance for RF ablation platform for thyroid nodules
Terumo reports first procedure using dual-sensor imaging system in US
Terumo Interventional Systems today announced the completion of the first procedure in the U.S. using its OpusWave dual-sensor imaging system. The procedure, performed by Dr. Annapoorna S. Kini, took place on June 15 at Mount Sinai Fuster Heart Hospital in New York. Somerset, New Jersey-based Terumo Interventional says it marks a "significant … [Read more...] about Terumo reports first procedure using dual-sensor imaging system in US
Johnson & Johnson begins carotid IVL study enrollment
Johnson & Johnson (NYSE:JNJ) today announced the initiation of its SKYWARD clinical program for a new Shockwave IVL system. The SKYWARD FDA investigational device exemption (IDE) study evaluates the novel SkyRunner carotid intravascular lithotripsy (IVL) system for the treatment of calcified carotid arteries prior to stenting. SkyRunner, … [Read more...] about Johnson & Johnson begins carotid IVL study enrollment
Johnson & Johnson launches ThermoCool SmartTouch ablation tech in Europe
Johnson & Johnson (NYSE:JNJ) announced today that it launched its dual-energy ThermoCool SmartTouch platform in Europe. The launch expands access in the region to dual-energy catheter ablation for personalized care across workflows, anatomies and procedural strategies. J&J's ThermoCool SmartTouch platform combines the ThermoCool … [Read more...] about Johnson & Johnson launches ThermoCool SmartTouch ablation tech in Europe
Corvention launches KardiaPSI balloon catheter in US with first cases
Corvention announced today that it completed the first case in the U.S. with its proprietary KardiaPSI balloon catheter. The procedure, performed by Dr. Alan Zajarias in St. Louis, marked the official start of a limited rollout for the balloon catheter. Flagstaff, Arizona-based Corvention won FDA clearance for the device in balloon aortic … [Read more...] about Corvention launches KardiaPSI balloon catheter in US with first cases
Medtronic brings PulseSelect pulsed field ablation tech to India
Medtronic (NYSE:MDT) announced the launch of its PulseSelect pulsed field ablation (PFA) platform in India. PulseSelect uses non-thermal energy to deliver cardiac ablation to treat AFib. The energy delivers pulmonary vein isolation while reducing the risk of damage to surrounding structures. Medtronic's system features nine electrodes on its … [Read more...] about Medtronic brings PulseSelect pulsed field ablation tech to India
Penumbra earns CE mark for Thunderbolt thrombectomy system
Penumbra (NYSE:PEN) announced today that it received CE mark approval for its Thunderbolt thrombectomy system for stroke. European approval for the computer-assisted vacuum thrombectomy (CAVT) technology comes just days after FDA clearance. Thunderbolt expands the company’s computer-assisted vacuum thrombectomy (CAVT) portfolio. It aims to … [Read more...] about Penumbra earns CE mark for Thunderbolt thrombectomy system
