Abbott (NYSE:ABT) announced today that the FDA approved the longer length (76 mm) Esprit BTK drug-eluting scaffold system. The longer Esprit BTK system received approval for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD). CLTI can cause extreme pain, open wounds that don’t heal and, … [Read more...] about Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Applications
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
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 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
Teleflex begins enrollment in resorbable magnesium scaffold study
Teleflex (NYSE:TFX) announced today that it began enrollment in the BIOMAG-III study of its Freesolve resorbable magnesium scaffold (RMS). Freesolve came to Teleflex through its 2025 acquisition of the Biotronik Vascular Interventions business. It features the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company … [Read more...] about Teleflex begins enrollment in resorbable magnesium scaffold study
