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
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Edwards Lifesciences, Medtronic score CMS win over TAVR
Edwards Lifesciences (NYSE: EW) and Medtronic (NYSE: MDT) are among the medtech companies praising CMS’s decision to expand Medicare coverage for TAVR to people with asymptomatic severe aortic stenosis. The finalized national coverage decision, published yesterday evening, also removes the evidence development (CED) requirement for symptomatic … [Read more...] about Edwards Lifesciences, Medtronic score CMS win over TAVR
Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
Medtronic (NYSE: MDT) has secured a CE mark for its Endurant stent graft, removing a treatment warning related to its use in ruptured abdominal aortic aneurysms (AAA). The Minnesota-run medtech giant received a similar FDA labeling change in late 2025. A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal … [Read more...] about Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
Medtronic wins expanded indication in Europe for Affera to treat VT
Medtronic (NYSE: MDT) has won an expanded CE mark indication for its Affera mapping and ablation system with Sphere-9 catheter to treat ventricular arrhythmias. The expanded indication, announced today, includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, the Sphere-9 catheter is the first … [Read more...] about Medtronic wins expanded indication in Europe for Affera to treat VT
RapidPulse raises $48M for thrombectomy tech as Medtronic invests
RapidPulse announced today that it closed a $48 million Series B financing, with Medtronic among the investors participating. Miami-based RapidPulse develops next-generation aspiration technology for treating acute ischemic stroke. Its latest funding adds to $10.5 million raised in 2022. Medtronic co-led the funding round alongside TechWald … [Read more...] about RapidPulse raises $48M for thrombectomy tech as Medtronic invests
Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic's recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic brings PulseSelect pulsed field ablation tech to India
Medtronic (NYSE:MDT) announced the launch of its PulseSelect pulsed field ablation (PFA) platform in India. PulseSelect uses non-thermal energy to deliver cardiac ablation to treat AFib. The energy delivers pulmonary vein isolation while reducing the risk of damage to surrounding structures. Medtronic's system features nine electrodes on its … [Read more...] about Medtronic brings PulseSelect pulsed field ablation tech to India
Medtronic completes acquisition of Scientia Vascular
Medtronic (NYSE:MDT) announced today that it completed its previously announced acquisition of Scientia Vascular for $550 million. In March, the medtech giant said it struck a deal to acquire Salt Lake City, Utah–based Scientia, which develops access products for treating complex neurovascular conditions. With the acquisition, Medtronic … [Read more...] about Medtronic completes acquisition of Scientia Vascular
Medtronic wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera
Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including FDA breakthrough device designation. The medtech giant said the FDA granted breakthrough device designation for its Sphere-9 catheter for the treatment of ventricular tachycardia (VT). At Heart Rhythm Society (HRS) 2026 in Chicago, the company … [Read more...] about Medtronic wins FDA breakthrough nod for Sphere-9 catheter, reports new clinical milestones for Affera
Medtronic leads $100M financing for artery denervation tech developer Pulnovo Medical
Pulnovo Medical announced today that it completed an oversubscribed $100 million strategic financing round led by Medtronic. Separate from the financing, the companies entered into a commercial agreement that contemplates potential future commercialization opportunities. Medtronic was joined by existing investors EQT, Qiming Venture Partners, … [Read more...] about Medtronic leads $100M financing for artery denervation tech developer Pulnovo Medical


![The Endurant stent graft system. [Image courtesy of Medtronic]](https://www.medicaltubingandextrusion.com/wp-content/uploads/2025/10/Endurant_Hero_woDS-1-300x195.jpg)






