Johnson & Johnson MedTech announced 12-month data from its SmartfIRE clinical trial of the ThermoCool SmartTouch SF catheter. The medtech giant said investigators presented findings at the annual meeting of the European Heart Rhythm Association (EHRA) in Vienna, Austria. Outcomes showed that the dual-energy catheter proved 86.9% effective when treating patients with high adherence to […]
Catheters
FDA clears Boston Scientific Bolt IVL system
Boston Scientific has received FDA clearance for its Bolt intravascular lithotripsy (IVL) system, according to the FDA’s 510(k) database. According to the FDA, it granted 510(k) clearance for the system on March 25, about two months post-submission (Jan. 27). The database included the RESTORE ATK (above the knee) trial for Bolt IVL in treating stenotic […]
Boston Scientific Farapulse PFA system shows superiority in head-to-head study with Medtronic cryoablation system
Boston Scientific announced new study findings demonstrating the superiority of its Farapulse pulsed field ablation (PFA) system. Data published in the New England Journal of Medicine showed Farapulse’s superiority in reducing atrial arrhythmia (AA) recurrence or treating symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF) compared to the Medtronic Arctic Front Advance cardiac cryoablation catheter. Boston Scientific […]
VVT Medical plans to go public on Toronto exchange
VVT Medical, a developer of minimally invasive treatments for venous insufficiency, announced that it has received conditional approval from the TSXv to list its common shares. The Kfar Saba, Israel–based company has already secured $6.5 million in funding toward its listing and seeks to reach at least $8 million in total financing. DXI Capital Corp. […]
Supira Medical closes $120M Series E, completes enrollment in ventricular assist device study
Supira Medical announced today that it completed an oversubscribed Series E financing round, bringing in $120 million. The clinical-stage Shifamed portfolio company also recently completed enrollment for its U.S. SUPPORT I Early Feasibility Study (EFS) evaluating its percutaneous ventricular assist device (pVAD) for treating high-risk percutaneous coronary intervention (HRPCI). New investors Novo Holdings and Qatar […]
Medtronic rolls out Affera PFA system in Sweden with more Nordic countries to follow
Medtronic announced today that it brought its Affera mapping and ablation system into clinical use for the first time in Sweden. Affera includes the Sphere-9 catheter and the Affera Prism-1 mapping software. The company initially won CE mark for the system about two years ago and plans to bring it to more Nordic countries after […]
Abbott is making an IVL play with FDA IDE nod
Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to enroll up to 335 subjects at […]
FDA clears Imperative Care’s Symphony 16F 82cm catheter
Imperative Care today announced FDA 510(k) clearance of its Symphony 16 Fr 82cm catheter for venous thrombosis and announced the first successful cases. Campbell, California-based Imperative Care said the catheter joins the Symphony Thrombectomy System’s 16 Fr 117 cm and 24 Fr 85 cm catheters. “The customized length of the 16 Fr 82 cm catheter […]
Medtronic recalls embolization device after reported deaths
The FDA deemed a recall of some Medtronic Pipeline Vantage embolization devices serious after multiple deaths related to the device. The recall involves removing Pipeline Vantage 027 device models from use and sale and updating instructions for Pipeline vantage 021 models. Medtronic’s Pipeline Vantage embolization devices with Shield Technology treat bulges in the artery walls […]
Perfuze wins FDA nod for access catheter, raises $24M
Perfuze announced today that it received FDA 510(k) clearance for its Zipline access catheter and secured significant funding. The Galway, Ireland–based medtech company picked up about $24 million (€22 million) in a follow-on funding round. Existing investors, including Earlybird, EQT Life Sciences, Seroba and SV Health, participated in the round. The company earmarked funds to […]
NanoVibronix announces reverse stock split
NanoVibronix (Nasdaq:NAOV) announced today that it intends to effect a reverse stock split of its common stock. The split comes at a ratio of one post-split share for every 11 pre-split shares. Tyler, Texas-based NanoVibronix expects the split to go into effect at 4:05 p.m. on March 13, 2025. It plans for its common stock […]
