Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
Vascular
Inari Medical has positive ClotTriever data
Inari Medical announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system. Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum. Results represent the largest prospective, multi-center, two-year dataset in deep-vein thrombosis (DVT) since the ATTRACT trial, Inari said in a […]
Boston Scientific has positive Agent DCB study results
Boston Scientific reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to […]
Nanoflex Robotics announces first U.S. surgical robot installation
Nanoflex Robotics announced today that it installed its first remote-ready robotics system for neurovascular procedures in the U.S. The installation took place at The Jacobs Institute, a nonprofit medical device innovation center in Buffalo, New York. Zurich, Switzerland-based Nanoflex designed its robotic system with a compact magnetic field generator and a navigation control unit. These […]
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary hypertension with associated heart failure. Paris-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina. Dr. Marat Fudim and […]
Endologix picks former Medtronic leader as new chief commercial officer
Endologix announced today that it appointed Mike Mathias as its new chief commercial officer (CCO), effective immediately. Mathias brings 30 years of experience leading commercial organizations within the cardiovascular area. He most recently served as VP of commercial operations at Limflow. He held that role from 2022 until Inari Medical acquired the chronic limb-threatening ischemia […]
BD initiates IDE trial of stent for treating peripheral arterial disease
BD announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed […]
Philips launches new Azurion neuro biplane system for neurovascular interventions
Philips announced today that it made major enhancements to its Azurion image-guided therapy system with a new launch. The Amsterdam-based medtech giant unveiled its new Azurion neuro biplane system at ECR 2024. It designed the system to streamline neurovascular procedures and help care teams make the right decisions and do so faster. This enables the […]
LivaNova to lay off 137 in Pennsylvania
LivaNova plans to lay off 137 employees at its Pittsburgh, Pennsylvania location by the end of this year. Shares of LIVN fell 0.7% at $50.37 apiece in midday trading today. The Pennsylvania Dept. of Labor and Industry included LivaNova in its January notices under the Worker Adjustment and Retraining Notification (WARN) Act. Layoffs began taking […]
J&J’s Cerenovus launches next-gen stroke revascularization catheter
Johnson & Johnson MedTech’s Cerenovus today announced the launch of its next-generation CereGlide 71 intermediate catheter with TruCourse. The catheter’s indication covers the revascularization of patients suffering from acute ischemic stroke. It joins the company’s planned CereGlide family of catheters set to enhance the Cerenovus Stroke Solutions portfolio. The company said it optimized the system […]
Innova Vascular has positive early commercial data for thrombectomy system
Innova Vascular today announced the successful early commercial use of its Laguna Thrombectomy System in California. The first physicians to use the system — Dr. Raj Khalsa and Dr. John Moriarty — reported positively after their initial cases. Khalsa touted the system’s easy preparation, strong trackability in challenging anatomies and effective clot extraction. “The design, […]