Amplitude Vascular Systems (AVS) today announced findings from the first 95 patients treated in its POWER PAD II U.S. pivotal study. POWER PAD II evaluates the company's pulsatile intravascular lithotripsy (PIVL) therapy. It assesses the safety and efficacy of the Pulse IVL system for treating moderate-to-severely calcified peripheral arterial … [Read more...] about AVS reports positive results for pulsatile IVL tech
About Sean Whooley
J&J’s Shockwave shares data supporting Javelin forward IVL
Johnson & Johnson MedTech‘s Shockwave Medical today announced one-year results in a study using its Javelin peripheral IVL catheter. Yesterday, the company shared findings from a separate intravascular lithotripsy (IVL) study. It presented findings at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Today, it shared … [Read more...] about J&J’s Shockwave shares data supporting Javelin forward IVL
BD completes enrollment in vascular covered stent study
BD (NYSE: BDX) today announced that it completed enrollment in the iliac artery patient cohort in its pivotal AGILITY study. AGILITY, an FDA investigational device exemption (IDE) study, evaluates the Revello vascular covered stent in patients with peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD initiated the trial earlier … [Read more...] about BD completes enrollment in vascular covered stent study
Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes
Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today. The IDE gives the device developer the green light to conduct a pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) … [Read more...] about Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes
More data supports Penumbra mechanical thrombectomy system
Penumbra (NYSE:PEN) announced additional results from its STORM-PE trial of computer-assisted vacuum thrombectomy (CAVT). The data release follows STORM-PE findings shared last week supporting the use of the company's Lightning Flash system at TCT 2025. Investigators shared additional results at this week's Vascular Interventional Advances (VIVA) … [Read more...] about More data supports Penumbra mechanical thrombectomy system
J&J’s Shockwave reports positive IVL data for below-the-knee lesions, CLTI
Johnson & Johnson MedTech‘s Shockwave Medical today announced one-year results supporting the use of its Shockwave peripheral IVL system. Shockwave shared findings from DISRUPT BTK II. The post-market study evaluates the safety and effectiveness of the company's intravascular lithotripsy (IVL) system for the treatment of calcified lesions … [Read more...] about J&J’s Shockwave reports positive IVL data for below-the-knee lesions, CLTI
Olympus issues label update for certain bronchoscopes related to endobronchial combustion
Olympus announced today that it made a voluntary corrective action to provide further clarification on the use of certain bronchoscopes. The company's global action aims to outline the safe and effective use of its bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures … [Read more...] about Olympus issues label update for certain bronchoscopes related to endobronchial combustion
InterVene wins FDA 510(k) for Recana thrombectomy catheter
InterVene announced today that it received FDA 510(k) clearance for its Recana thrombectomy catheter system. FDA clearance covers the treatment of venous in-stent restenosis (ISR) and native vessel obstructions. It comes just over a year after the company raised $13 million in its Series A funding round to support Recana. Redwood City, … [Read more...] about InterVene wins FDA 510(k) for Recana thrombectomy catheter
Recor Medical shares positive renal denervation data at TCT
Recor Medical today announced results from two clinical studies evaluating its Paradise ultrasound renal denervation (uRDN) system. Tokyo-based Otsuka’s U.S.-based Recor subsidiary developed Paradise for the treatment of resistant hypertension. Recor Medical received a landmark FDA nod for its Paradise system in November 2023. It also holds CE … [Read more...] about Recor Medical shares positive renal denervation data at TCT
Surmodics reports real-world Pounce thrombectomy system findings
Surmodics (Nasdaq:SRDX) announced results from a sex-specific analysis of real-world patients in a study of its Pounce thrombectomy system. The analysis evaluated 160 acute, subacute and chronic thrombotic limb ischemia patients from the PROWL registry. Dr. Peter Monteleone presented findings at the 2025 Transcatheter Cardiovascular Therapeutics … [Read more...] about Surmodics reports real-world Pounce thrombectomy system findings
