Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic's recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Catheters
Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Johnson & Johnson (NYSE:JNJ) announced today that it received FDA approval for its dual-energy ThermoCool SmartTouch SF platform (DE STSF). The ThermoCool SmartTouch platform combines the ThermoCool SmartTouch SF catheter with the TruPulse generator. Combining the irrigated contact-force-sensing catheter with TruPulse enables the delivery of … [Read more...] about Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Xeltis has first commercial implant of vascular access device for hemodialysis
Xeltis announced today that it began European commercialization efforts for its aXess vascular access device. Dr. Dominik Liebetrau at Artemed Klinikum Munich South, Germany, completed the first successful commercial treatment with aXess. aXess, the company’s restorative vascular access conduit, is designed to enable the creation of a new, … [Read more...] about Xeltis has first commercial implant of vascular access device for hemodialysis
Penumbra enrolls first patient in distal acute stroke thrombectomy study
Penumbra (NYSE:PEN) announced today that it initiated the FORWARD study of its mechanical thrombectomy technology. Alameda, California–based Penumbra's real-world, prospective, multi-center study will collect safety and efficacy data on mechanical thrombectomy. That includes computer-assisted vacuum thrombectomy (CAVT) and modulated aspiration … [Read more...] about Penumbra enrolls first patient in distal acute stroke thrombectomy study
Endogenex completes enrollment in trial of endoscopic diabetes treatment
Endogenex announced today that it completed enrollment in the ReCET clinical study of its endoscopic diabetes treatment. ReCET enrolled 350 patients across approximately 40 clinical sites in the U.S. and Australia. It evaluates the safety and effectiveness of the Endogenex System in adult patients with T2D whose blood glucose levels are … [Read more...] about Endogenex completes enrollment in trial of endoscopic diabetes treatment
Reflow Medical enrolls first patient in retrievable scaffold trial
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
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
