Supply chain updates and innovative devices

Structural heart robotics startup Capstan Medical designed its mitral valve implant with a self-expanding nitinol frame. [Photo courtesy of Capstan Medical]

What a year it was for nitinol, from the raw melters that make this medtech metal to big advances in the development and use of groundbreaking medical devices enabled by nitinol.

I and the other editors of Medical Design & Outsourcing, MassDevice and DeviceTalks recently wrapped up 2024 with a DeviceTalks Weekly conversation about medtech’s biggest stories of 2024. My personal pick was nitinol, and while I’ll recap my points below, I’d encourage readers to listen to the whole episode at the end of this post.

Big leaps for nitinol-enabled medical devices

The Ablative Solutions Peregrine infusion catheter is designed to deliver alcohol through three nitinol microneedles (shown here with a drop of alcohol on each). [Photo courtesy of Ablative Solutions]

Medical devices that use nitinol include minimally invasive implants like catheter-delivered brain computer interfaces (BCIs) and heart valves, but also new systems and therapies for treating some of the leading causes of death, conditions like heart failure, blood clots, hypertension and atrial fibrillation (AFib).

Nitinol in medtech: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism

For example, by December 2024, Medtronic’s nitinol-enabled Symplicity Spyral renal denervation (RDN) system had been treating hypertension patients for a year after its FDA approval in November 2023, while another device startup was developing an RDN system that uses nitinol in a different way.

Related: What Medtronic learned on its long road to RDN approval

The nitinol Synchron Stentrode BCI implant senses motor signals from inside the brain’s superior sagittal sinus. [Illustration courtesy of Synchron]

We started 2024 with coverage of nitinol BCI implant developer Synchron that included a cover story with co-founder and CEO Dr. Tom Oxley, an interview with Synchron CTO Riki Banerjee about BCI manufacturing and outsourcing, and a first look at Synchron’s manufacturing partner, Acquandas. We featured Synchron Director of Neural Interfaces and Mechanical Systems in our MDO Min-Vasive Medtech webinar series in September, and checked back in with Oxley in September as Synchron reported positive study results and planned a pivotal trial for FDA approval.

And in April 2024, the FDA approved Abbott’s TriClip system, which uses nitinol for transcatheter edge-to-edge repair (TEER) of tricuspid valves in the heart. Meanwhile, structural heart startup Capstan Medical reported progress on its system for robot-assisted heart valve replacements in 2024.

Pulse field ablation was nitinol’s big success story of 2024

The Medtronic PulseSelect pulsed field ablation (PFA) system has a nitinol superstructure that allows it to compress down inside a catheter for delivery before expanding inside a patient. [Image courtesy of Medtronic]

Nitinol-enabled pulse field ablation (PFA) technology was what really stood out in 2024. Medtronic reported the first cases with its PulseSelect PFA system in February, and now we’ve got Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster in the PFA market as well with Abbott looking to join soon. (Our story on the Abbott Volt PFA design was one of our most-read posts for 2024.)

Nitinol’s essential for PFA catheters, which go into the heart and expand into a predetermined shape (we featured several PFA catheter designs on the cover of our September 2024 magazine), then generate an energy field to open holes in heart muscle cells. That’s called electroporation, and it kills those myocytes to prevent AFib. At the same time, these energy fields do not affect nerve cells, so PFA minimizes the risk of harm to patients during and after these catheter ablations.

Medtronic’s Affera Sphere-360 pulsed field ablation catheter is adjustable, allowing the nitinol electrode to take different shapes inside a patient. [Illustration courtesy of Medtronic]

In late 2023, Medtronic’s Pulse Select won the first FDA approval for PFA, but in October 2024 Medtronic won another PFA approval for the Affera Sphere-9 mapping and ablation system, which uses nitinol to deliver the ablation energy in a new way. PulseSelect and PFA catheters from other device developers use gold or platinum-iridium electrodes. But Medtronic’s Affera Sphere-9 PFA system uses the entire expanding nitinol structure as a global electrode. Medtronic’s investigational Affera Sphere-360 PFA system system is similar in that way, but also uses nitinol to take different shapes inside a patient.

Nitinol was behind some of the biggest medtech deals of 2024

The V-Wave Ventura interatrial shunt (featuring a nitinol frame) is shown here anchoring inside a patient’s heart before the guidewire is retracted. [Image courtesy of V-Wave]

Take a look at the largest medtech deals of 2024 at MassDevice and you’ll see plenty related to nitinol.

We covered nitinol technology at V-Wave after J&J announced its $1.7 billion acquisition of the cardiac implant developer.

Another nitinol-related deal was Boston Scientific’s $1.18 billion purchase of Silk Road Medical, which develops tech for transcarotid artery revascularization (TCAR), a minimally invasive procedure to prevent strokes in carotid artery disease patients,

And Edwards Lifesciences — which uses nitinol for its structural heart systems — in 2024 acquired heart failure implant developer Endotronix and announced a deal to purchase JenaValve Technologies. Endotronix and JenaValve both use nitinol for their devices. That pending JenaValve purchase could be the first big deal of 2025 if it closes soon.

Nitinol supply chain deals

Big nitinol news from late 2023 primed the year that followed, when Resonetics got into the nitinol melting business with its $900 million acquisition of Memry and Smart Materials in October 2023. In January 2024, Confluent Medical Technologies announced a partnership with ATI to expand its nitinol melting infrastructure.

In the months that followed, Johnson Matthey sold its Medical Device Components (MDC) business for $700 million to private equity firm Montagu, creating a newly independent nitinol device CDMO. Later in the year, MDC announced a purchase of its own with the acquisition of nitinol-based medical components maker Lighteum.

In the final months of 2024, MDO spoke with three of the world’s top medical nitinol melters to help device developers and manufacturers better understand the supply chain and trends in nitinol prices and lead times:

Hear what my fellow editors had to say as they looked back at 2024 in the DeviceTalks Weekly episode below.