Johnson & Johnson (NYSE: JNJ) is launching the latest version of its intravascular lithotripsy catheter for cracking calcium within the coronary arteries, which the company said it designed to cut treatment times in half. The Shockwave C2 Aero Fly catheter delivers ultrasonic energy at double the speed of its previous version and with less … [Read more...] about J&J launches faster Shockwave coronary catheter in the US
Catheters
E2’s pulmonary embolism platform claims two FDA clearances
Endovascular Engineering (E2) has received a pair of FDA clearances for its pulmonary embolism treatment platform, spanning its dual-action thrombectomy system and hardware that returns filtered blood to the patient. The Hēlo system combines continuous vacuum aspiration with physical agitation to help break up the blood clot. Its catheter starts … [Read more...] about E2’s pulmonary embolism platform claims two FDA clearances
J&J delivers Shockwave data sustaining below-the-knee gains for two years
Johnson & Johnson MedTech (NYSE: JNJ) shared extended clinical findings from its Shockwave intravascular lithotripsy system, from a study aimed at clearing calcified vessel blockages below the knee in patients with peripheral artery disease. In late-breaking data presented at the Vascular InterVentional Advances 2026 conference in Las Vegas, … [Read more...] about J&J delivers Shockwave data sustaining below-the-knee gains for two years
Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
Medtronic (NYSE:MDT) has secured a breakthrough designation from the FDA for a version of its drug-coated balloon aimed at unblocking arteries below the knee, following years of development. The In.Pact BTK catheter is slated for an international, randomized pivotal trial that plans to enroll about 400 participants with peripheral artery disease … [Read more...] about Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
BD’s IV catheters plant in Utah marks 70 years
BD (NYSE:BDX) is celebrating the 70th birthday of its major manufacturing facility in Utah, which the company said produces billions of molded components each year. Located in the town of Sandy just south of Salt Lake City, the site was founded in 1956 under Deseret Pharmaceuticals. BD acquired the plant in 1986, and today it’s home to a … [Read more...] about BD’s IV catheters plant in Utah marks 70 years
Perfuze’s super-bore stroke catheter tops conventional, cyclic aspiration in bench study
Following FDA clearance earlier this year, Perfuze is putting forward new data comparing its super-bore aspiration catheter to conventional suction methods for removing stroke-causing blood clots, as well as the emerging approach of cyclic aspiration. The three-way benchtop study of the company’s Millipede88 catheter, tested with in vitro models … [Read more...] about Perfuze’s super-bore stroke catheter tops conventional, cyclic aspiration in bench study
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon
XCath Robotics receives FDA breakthrough nod for Iris system
XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for … [Read more...] about XCath Robotics receives FDA breakthrough nod for Iris system
Luma Vision wins expanded FDA nod for its cardiac procedure software
Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform. The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the … [Read more...] about Luma Vision wins expanded FDA nod for its cardiac procedure software
Abbott earns FDA approval for new dual-energy ablation catheter
Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
