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 […]
Catheters
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 […]
Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
Second Heart Assist today announced data from a study highlighting the performance of its Whisper device against a competitive heart pump. The study showed that Whisper — a next-generation percutaneous mechanical circulatory support (pMCS) system — caused significantly less hemolysis than the widely used Johnson & Johnson MedTech/Abiomed Impella CP when both pumps were operated […]
Medtronic says new study backs Prevail paclitaxel-coated balloon
Medtronic announced results from a registry highlighting the effectiveness of the Prevail drug-coated balloon (DCB). Dr. Sacharias von Koch of the Deptartment of Cardiology and Clinical Sciences at Lund University, Skåne University Hospital in Sweden presented findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) at Cardiovascular Research Technologies (CRT) 2025 in Washington, D.C. […]
Lungpacer wins FDA IDE for AeroNova system
Lungpacer Medical announced today that it received FDA investigational device exemption (IDE) to begin a trial for its AeroNova system. The STARI (stimulation to activate respiration) trial evaluates the feasibility of the investigational AeroNova system. It looks at the system in patients suffering from moderate to severe Acute Hypoxemic Respiratory Failure (AHRF). AeroNova, a novel, […]
Reflow Medical expands global reach with European subsidiary
Reflow Medical announced today that it opened a European subsidiary in Landsberg am Lech, Germany, to expand outside the U.S. The company said its strategic expansion strengthens its international presence and enhances its ability to serve markets globally. SVP and GM Knut Saurteig leads the subsidiary, called Reflow Medical Europe GmbH. Under his leadership, the […]
Stryker’s Inari Medical launches Artex thrombectomy system
Inari Medical — now part of Stryker — announced that it launched its Artix thrombectomy system for arterial thrombectomies. The company built Artix for the distinct needs of the peripheral arterial system, according to a news release. It marks Inari’s inaugural entry into the arterial space. First look: Inari Medical’s Artix thrombectomy system for acute limb […]
FTC challenges private equity firm’s acquisition of Surmodics
The U.S. Federal Trade Commission (FTC) has sued to block the planned acquisition of medical device company Surmodics by GTCR. According to a news release, GTCR also owns a majority stake in Biocoat. The FTC says Biocoat is the second-largest provider of outsourced hydrophilic medical device coatings, behind only Surmodics. As a result, the FTC believes the deal […]
