Merit Medical Systems (Nasdaq:MMSI) announced today that it agreed to acquire Cook Medical's lead management portfolio for $210 million. Cook Medical's lead management business provides medical devices and accessories used in lead management procedures. These procedures occur in patients who need a pacemaker or an implantable … [Read more...] about Merit Medical to buy Cook Medical’s lead management portfolio
Catheters
FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads. The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed … [Read more...] about FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Penumbra wins CE mark for computer-assisted thrombectomy tech
Penumbra (NYSE:PEN) announced today that it received CE mark approval for its computer-assisted vacuum thrombectomy (CAVT) technologies. The Lightning Flash 2.0 and Lightning Bolt 7 offerings from the Alameda, California-based company both picked up European approval. Penumbra said approval makes its Lightning products the only CAVT systems … [Read more...] about Penumbra wins CE mark for computer-assisted thrombectomy tech
Biotronik earns expanded FDA nod for pacing lead, delivery catheter system
Biotronik announced today that it received FDA approval for its Selectra 3D catheter and Solia S lead for use in left bundle branch area pacing (LBBAP). The FDA's approval of the new labeling for the pacing combination makes the products the first and only stylet-driven lead and dedicated delivery catheter system approved by the FDA for LBBAP, … [Read more...] about Biotronik earns expanded FDA nod for pacing lead, delivery catheter system
J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
Johnson & Johnson MedTech's Shockwave Medical today announced the full U.S. launch of its Shockwave E8 peripheral IVL catheter. Santa Clara, California-based Shockwave launched the intravascular lithotripsy (IVL) catheter following FDA clearance. It designed the catheter to optimize the treatment of patients with calcified femoro-popliteal … [Read more...] about J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
AngioDynamics wins CE mark for atherectomy system
AngioDynamics (Nasdaq:ANGO) announced today that it received CE mark approval for its Auryon atherectomy system. Latham, New York-based AngioDynamics designed Auryon for the treatment of peripheral artery disease (PAD). That includes critical limb ischemia (CLI) and in-stent restenosis (ISR). Auryon uses revolutionary solid-state laser … [Read more...] about AngioDynamics wins CE mark for atherectomy system
FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Jupiter Endovascular announced today that the FDA approved an investigational device exemption (IDE) study for its Vertex system. The company can now conduct the SPIRARE II U.S. pivotal study for the pulmonary embolectomy system. Menlo Park, California-based Jupiter Endovascular only just came out of stealth mode, spinning out of Neptune Medical … [Read more...] about FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial. The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company's Omnypulse platform. The J&J unit designed … [Read more...] about J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
Obvius Robotics announced today that the FDA granted breakthrough device designation for its Certa access system for central venous catheterization (CVC). CVC procedures require access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of … [Read more...] about Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
