Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales
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xDot Medical can begin FDA IDE study of vascular closure device
xDot Medical announced today that it received FDA investigational device exemption (IDE) approval for its access management system (AMS). IDE approval enables the company to initiate a pivotal clinical trial evaluating the AMS for the closure of femoral arterial and femoral venous access sites. The company plans to enroll patients undergoing … [Read more...] about xDot Medical can begin FDA IDE study of vascular closure device
Johnson & Johnson launches next-gen Shockwave IVL catheter
Johnson & Johnson (NYSE:JNJ) today announced the global launch of the Shockwave C2 Aero coronary intravascular lithotripsy (IVL) catheter. The next-generation catheter leverages Shockwave IVL's unique mechanism of action and the safety and effectiveness profile of its legacy catheters. It features improved deliverability, enhanced lesion … [Read more...] about Johnson & Johnson launches next-gen Shockwave IVL catheter
Adagio ventricular ablation tech performs well in clinical trial
Adagio Medical (Nasdaq:ADGM) today announced new six-month results from its FULCRUM-VT clinical trial evaluating its ablation technology. FULCRUM-VT evaluates the company’s vCLAS cryoablation technology for treating cardiovascular disease. Laguna Hills, California-based Adagio built its vCLAS cryoablation catheter on its proprietary ultra-low … [Read more...] about Adagio ventricular ablation tech performs well in clinical trial
Johnson & Johnson MedTech announces updates to Varipulse, new ultrasound catheter
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] today announced the full commercial release of its NuVision Nav ultrasound catheter. Additionally, the company announced the introduction of the Varipulse Plus platform. Varipulse Plus represents an update to the existing Varipulse pulsed field ablation (PFA) … [Read more...] about Johnson & Johnson MedTech announces updates to Varipulse, new ultrasound catheter
Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement
Orchestra BioMed (Nasdaq:OBIO) announced today that it entered into a termination and right of first refusal agreement with Terumo. The agreement relates to the New Hope, Pennsylvania–based company's Virtue Sirolimus AngioInfusion Balloon (SAB). It supersedes and terminates a prior distribution agreement between the companies and grants Terumo a … [Read more...] about Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement
Recor Medical’s Paradise renal denervation tech wins Japanese approval
Otsuka Medical Devices announced today that Japanese authorities approved the Recor Medical 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 … [Read more...] about Recor Medical’s Paradise renal denervation tech wins Japanese approval
How Shockwave’s Javelin IVL catheter breaks up blood-blocking calcium where balloons can’t reach
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
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
NanoVibronix completes pilot study for UroShield device
NanoVibronix (Nasdaq:NAOV) announced today that it completed the first phase of a randomized controlled trial for its UroShield device. Researchers at the University of Michigan completed the first phase of the trial for UroShield, a portable ultrasonic therapeutic device. UroShield utilizes patented low-intensity surface acoustic wave (SAW) … [Read more...] about NanoVibronix completes pilot study for UroShield device
