The top nitinol cardiac medtech news of 2025 (so far)

Nitinol innovation in cardiac medtech is not slowing down in 2025, with new devices and systems hitting milestones as device developers put the latest learnings about this nickel-titanium alloy to work.

We’ll update this page throughout the year. In the meantime, you can visit Medical Design & Outsourcing‘s new nitinol hub to keep up with our latest nitinol news and coverage.

Capstan Medical

One of the most exciting milestones was Capstan Medical‘s first-in-human mitral valve replacement procedures using its robot-assisted catheter delivery system.

CEO Maggie Nixon gave us an update on what’s next for her structural heart surgical robotics startup (which uses nitinol in its mitral and tricuspid valve implants) and offered advice for working with nitinol and getting funded by Intuitive Ventures, while new R&D head Greg Dachs sat down with us for a live interview and Q&A from our webinar audience.

Edwards Lifesciences Sapien M3

Edwards Lifesciences won a first-of-its-kind regulatory approval with a CE mark for its new Sapien M3 transfemoral transcatheter mitral valve replacement (TMVR) system, which uses a nitinol implant to anchor the valve implant in a patient’s heart.

We interviewed VP of Engineering Darshin Patel — who led the system’s development — to learn more about its design, solutions to technical challenges, and lessons for other device developers from the project. (Ahead of the Sapien M3 news, we held a live interview and webinar Q&A with nitinol expert Ming Wu, the retired SVP of engineering at Edwards Lifesciences.)

Medtronic’s nitinol-enabled medtech

Our March minimally invasive medtech magazine‘s cover story recapped a presentation by Medtronic CEO Geoff Martha on the devices and technologies driving growth at the world’s largest medical device company. Many are enabled by nitinol, including pulsed field ablation (PFA) systems for treating atrial fibrillation (AFib) and the Evolut FX+ transcatheter aortic valve replacement (TAVR) system.

That March magazine included nitinol coverage beyond Medtronic, so check it out if you haven’t had a chance.

More recently, Medtronic reported positive clinical outcomes from two studies of its Affera PFA technologies as it continued rolling out the Affera Sphere-9 catheter and Prism-1 mapping software. Medtronic also shared five-year data from its Evolut Low Risk Trial, saying it confirmed the TAVR system delivers durable clinical outcomes and strong valve performance in low-risk aortic stenosis patients.

Abbott Volt PFA

Abbott announced new study data demonstrating the safety and efficacy of its Volt PFA system, saying the study showed the investigational device’s ability to achieve results with fewer therapy applications than PFA systems that are already on the market.

Following up on our first interview about the Abbott Volt PFA catheter in 2024 with Dr. Christopher Piorkowski, the chief medical officer of Abbott’s electrophysiology division, we’ve gone deeper into the device’s design and development, specifically how the team’s first PFA system’s energy waveform and balloon-in-basket form factor takes advantage of learnings from first-generation devices at competitors like Medtronic, Boston Scientific and Johnson & Johnson MedTech.

Johnson & Johnson MedTech cardiac ablation

J&J MedTech had a Class I recall on its Varipulse PFA system following reports of neurovascular events in patients treated with cardiac ablation for AFib. An investigation found potential safety factors that could apply to other PFA technologies.

J&J MedTech also presented 12-month data from its SmartfIRE clinical trial of its ThermoCool SmartTouch SF and secured a CE mark for the dual-energy catheter, which treats AFib with radiofrequency (RF) and pulse field ablation and uses nitinol for contact-force sensing.

Boston Scientific Faraflex PFA

Boston Scientific announced the first-in-human procedures using its next-generation Faraflex PFA and mapping catheter, which has a different design than the first-generation Farawave catheter (though both use nitinol).

We learned more about the investigational Faraflex device in an interview with Dr. Brad Sutton, the chief medical officer of Boston Scientific’s Atrial Solutions Business, which includes PFA systems for treating AFib.

Nanosecond PFA at Pulse Biosciences

We’re still learning so much about PFA, and now there’s nanosecond PFA (nsPFA), being developed by Pulse Biosciences, led by medtech vet Paul LaViolette, who said in a Medical Design & Outsourcing interview that “PFA is unique, PFA is disruptive, and nsPFA looks like a shining star within that field.”

He and Chief Technology Officer Darrin Uecker discussed the technology, which uses nitinol for self-expanding devices to deliver the energy for cardiac ablation, though there are other applications for nsPFA.

Stryker buys Inari Medical

Stryker purchased Inari Medical for about $5 billion in February. Inari’s portfolio includes nitinol-enabled devices and systems like the FlowTriever for pulmonary embolism.

Cardiac Dimensions Carillon Mitral Contour System

Cardiac Dimensions raised $53 million in Series E funding to advance its Carillon Mitral Contour System. In an interview with Medical Design & Outsourcing, Cardiac Dimensions President and CEO Rick Wypych explained the technology, how the system was developed, and discussed how the company manufactures the nitinol implant.

Merit Medical Systems Bloom

Merit Medical Systems says the first patient has been enrolled in a study of its Bloom micro occluder system, a minimally invasive heart implant designed to treat patent ductus arteriosus (PDA) in premature infants. Delivered by a catheter, the self-expanding device blocks blood flow to close that hole in the heart.

Fire1 Norm

Fire1 announced positive results from the first-in-human study of its novel implantable heart failure (HF) management system. The Fire1 Norm System includes a crown-shaped, nitinol-based sensor implant and a wearable belt receiver for remote management of patients with HF. Fire1 announced a $120 million fundraise for the technology in January.

Endospan Nexus

Endospan presented 30-day results from a study evaluating its Nexus aortic arch stent graft system, which is made of nitinol and polyester. The device developer said the results were promising and suggested the device may be an acceptable alternative to open aortic arch replacement in select patients at high risk for open surgery.

Senior Editor Danielle Kirsh and Associate Editor Sean Whooley contributed to this report.