Shockwave’s novel Javelin intravascular lithotripsy catheter focuses acoustic energy forward to clear a path through calcium-clogged blood vessels. Johnson & Johnson MedTech’s Shockwave Medical aims to deliver intravascular lithotripsy (IVL) to a different type of blood vessel with a first-of-its-kind catheter platform. The Javelin … [Read more...] about How Shockwave’s Javelin IVL catheter breaks up blood-blocking calcium where balloons can’t reach
Latest News on Medical Tubing & Extrusion
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 … [Read more...] about Medtronic recalls embolization device after reported deaths
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 … [Read more...] about Perfuze wins FDA nod for access catheter, raises $24M
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 to continue trading on … [Read more...] about NanoVibronix announces reverse stock split
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 … [Read more...] about Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
Medtronic says new study backs Prevail paclitaxel-coated balloon
Medtronic (NYSE: MDT) 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 … [Read more...] about Medtronic says new study backs Prevail paclitaxel-coated balloon
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 … [Read more...] about Lungpacer wins FDA IDE for AeroNova system
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. … [Read more...] about Reflow Medical expands global reach with European subsidiary
Stryker’s Inari Medical launches Artix 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. The combined aspiration plus mechanical … [Read more...] about Stryker’s Inari Medical launches Artix thrombectomy system
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 … [Read more...] about FTC challenges private equity firm’s acquisition of Surmodics
