nitinol Archives - Medical Design Sourcing

First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks

The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that’s unique within Medtronic’s PFA device portfolio.

The Medtronic Sphere-360 pulsed field ablation catheter is adjustable, allowing it to take different shapes inside a patient. [Illustration courtesy of Medtronic]

Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world’s largest device manufacturer.

In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac Ablation Solutions, discussed the Sphere-360’s design and features.

The large-lattice, over-the-wire PFA Sphere-360 catheter — which Medtronic purchased through its acquisition of Affera — is investigational in the EU …

What Synchron leaders learned from developing a stent-based BCI

This close-up shows one of the electrodes on Synchron’s Stentrode brain implant. [Image courtesy of Synchron]

Synchron’s efforts to develop, manufacture and commercialize its groundbreaking brain-computer interface system holds lessons for device developers who are designing increasingly miniaturized implants for minimally invasive delivery.

In recent months and years, we’ve asked Synchron leaders to share their advice as they studied the safety of their nitinol Stentrode implant, refined the implant’s design and manufacturing process, and launched a clinical trial under an investigational device exemption from the FDA, which previously awarded Synchron with breakthrough device designation.

‘Take it step by step’

In a wide-ranging interview with Medical Design & Outsourcing, Synchron CEO and co-founder Dr. Tom Oxley offered some advice specifically for device desig…

Who is Acquandas? Its thin film manufacturing goes beyond Synchron

This nitinol thin film actuator made by Acquandas with a film thickness of 50 µm can pull 550 times its own weight. [Image courtesy of Acquandas]

Acquandas is a thin-film device manufacturer that’s now partially owned by brain-computer interface developer Synchron.

Rodrigo Lima de Miranda founded Acquandas in 2012 based on microsystem technology he developed for his doctoral thesis, where he was trying to develop a shape memory material made with thin-film deposition.

The Kiel, Germany-based contract manufacturer now uses the Nanolab cleanroom facilities at Kiel University and is growing its team of around 22 employees.

Beyond neurotech applications like Synchron’s Stentrode, the Acquandas technology has promising potential for cardiac ablation, renal denervation, opthamology, nerve stimulation, passive microimplants, microneedles, and smart actuators and springs, Lima de Miranda said …

Confluent invests to expand ATI nitinol melting infrastructure

NEWS RELEASE: Confluent Announces Significant Investment in ATI Nitinol Melt Expansion

Confluent Becomes ATI’s Fulfillment Partner for Medical Nitinol

Scottsdale, AZ- Confluent Medical Technologies (Confluent) announced that it has partnered with ATI to invest more than $50 million over the next several years in ATI’s Nitinol melt and materials conversion infrastructure. With this significant investment, which will more than triple ATI’s melt capacity for medical Nitinol, Confluent will become ATI’s fulfillment partner and provide a suite of value-add services and order-fulfillment for ATI medical Nitinol mill product.

Confluent CEO and President Dean Schauer [Photo courtesy of Confluent]

“The growth in Neurovascular, Electrophysiology, Structural Heart, Peripheral Vascular, and Orthopedic device markets is driving an 18% growth rate (CAGR) in Nitinol demand. Given the substantial equipment and infrastru…

Nitinol machining and finishing for medical devices

Medtronic uses six nitinol wire struts for each Harmony transcatheter pulmonary valve (TPV).[Photo courtesy of Medtronic]

Nitinol machining and finishing are the final steps on this nickel-titanium alloy’s journey from the earth’s crust into the hands of doctors and bodies of patients as medical devices.

We’ve previously covered how medical nitinol is mined and melted into raw material and then processed into nitinol wires, tubes and sheets for device manufacturers to use in medical devices, components or parts.

Laser cutting nitinol tubes and sheets is the most common way to manufacture nitinol medical devices, components and parts. Laser cutting is used for common products including stents, heart valves, inferior vena cava (IVC) filters and most other nitinol implants.

More advanced than fiber lasers, femtosecond lasers can cut medical grade nitinol with ultra precision without…

How alcohol could make renal denervation for hypertension faster and simpler

Ablative Solutions President and CEO Kate Rumrill [Photo courtesy of Ablative Solutions]

Ablative Solutions is developing the Peregrine renal denervation (RDN) system to treat hypertension. The company hopes to follow Recor Medical and Medtronic in winning FDA approval for the system.

“As a small company, it’s definitely better to be a fast follower than it is to be first to market,” Ablative Solutions CEO Kate Rumrill said in an interview. “I’m excited for Medtronic and Recor and their first year of sales and having these larger companies out there, doing some of that early work as far as market awareness and market adoption.”

Medtronic’s Symplicity Spyral RDN system uses radiofrequency (RF) energy, while Recor’s Paradise system uses ultrasound. Peregrine doesn’t deliver energy at all, instead using alcohol as a neurolytic agent.

“There …

Resonetics closes $900M nitinol deal and rebrands Memry and Smart Materials

Nitinol is used for a variety of medtech applications. [Photo via Adobe Stock]

Resonetics has closed on its $900 million acquisition of the SAES Getters medical nitinol business.

Nashua, New Hampshire-based Resonetics said it will rebrand Memry Corporation and SAES Smart Materials as Resonetics.

The Smart Materials business creates raw nitinol alloy from nickel and titanium and produces nitinol wires, bars, ribbons and sheets. The Memry business offers electric discharge machining, laser processing, centerless grinding, and nitinol tubing, sheet, and wire fabrication.

Those two companies have around 600 employees at facilities in Bethel, Connecticut, New Hartford, New York, and Menlo Park, California.

Nitinol has superelastic and shape memory properties that make it uniquely useful for a variety of medical applications. Medical device developers are finding new and improved ways to use nit…

FTC concludes antitrust investigation of $900M SAES-Resonetics nitinol deal

Nitinol is used for a variety of medtech applications. [Photo via Adobe Stock]

The Federal Trade Commission has closed its antitrust investigation into Resonetics’ planned $900 million purchase of the SAES Getters medical nitinol business.

Milan, Italy-based SAES said it and Resonetics “will define the timing to finalize the closing of the transaction” in the coming days and will provide further updates.

The company did not say whether the FTC will allow the sale without conditions, but it doesn’t sound like the agency or the Department of Justice will sue over the transaction. More information was not immediately available.

Nashua, New Hampshire-based Resonetics signed a binding agreement in January 2023 to buy the medical nitinol division from SAES, including U.S. subsidiaries Memry Corp. and SAES Smart Materials. The business supplies medical device manufacturers with ra…

Shunt device startup wants to break barriers in nitinol and heart sensing

Adona Medical is designing its adjustable heart shunt device with pressure sensors on both sides of the heart. [Illustration courtesy of Adona Medical]

Medical devices have yet to tap nitinol’s shape memory properties, but that’s just one breakthrough Adona Medical hopes to achieve with its adjustable, bi-atrial-sensing heart shunt.

Adona Medical co-founder and CEO Brian Fahey’s presentation on his shunt device startup’s aspirations elicited palpable interest from the cardiologists in the room at CSI Frankfurt.

“You plan to disrupt two fields in heart failure?” asked Dr. Daniel Burkhoff, the director of heart failure, hemodynamics and MCS research at the Cardiovascular Research Foundation’s Clinical Trials Center.

“We’re going to try,” Fahey replied. “Our plan is to improve patient care.”

Fahey has publicly said little abo…

After recall and relaunch, Medtronic wants to go global with its Harmony valve

Each Medtronic Harmony valve is sewn by hand to attach laser-cut pig tissue to the nitinol that makes this minimally invasive heart implant possible.

Medtronic’s Harmony transcatheter pulmonary valve (TPV) is made of nitinol wire, polyester and laser-cut pig tissue, all sewn together by hand. [Photo courtesy of Medtronic]

Medtronic’s Harmony transcatheter pulmonary valve (TPV) design is paying off after engineers solved a delivery catheter recall and relaunched the system this year.

The Harmony TPV uses pig tissue, shape-memory alloy nitinol and manufacturing techniques old and new to solve a special challenge for children and adults.

The catheter-placed Harmony valve offers a minimally invasive way to improve the flow of blood to the lungs and delay open-heart surgery for congenital heart disease. Congenital heart defects are present in about 40,000 babies born each year, making it the most …

Medical nitinol manufacturing: How this nickel-titanium alloy is made for medical devices

Titanium sponge (pictured) is a key ingredient for medical nitinol manufacturing. [Photo by Alexey Rezvykh via Adobe Stock]

Nitinol (NiTi) might be the hottest material in the medical device industry as manufacturers find new applications for this superelastic, shape-memory metal.

Nitinol — an alloy of nickel and titanium — takes a long, hot journey from the Earth’s crust to the deepest parts of the human anatomy. It starts with ore heaved from deep mines undergound or stripped from the soil and refined into titanium and nickel.

To make raw nitinol, suppliers melt pure titanium — in the form of sponge or top-shelf crystal bar — with pure nickel. They must be combined at a roughly 1:1 atomic ratio, which comes out to around 55% nickel and 45% titanium. A nitinol at that ratio would be referred to as nitinol 55.

To be used for medical devices, the resulting nitinol should meet standards set by…

How Medtronic uses nitinol to improve the structure and effectiveness of heart devices

Tim Laske is Medtronic’s VP of Research & Business Development, Cardiac Ablation Solutions. [Photo courtesy of Medtronic]

Tim Laske, VP of research and business development for Medtronic‘s cardiac ablation solutions business, discusses the challenges of designing devices for the heart and explores the properties of nitinol.

The heart is often one of the most underappreciated aspects of human anatomy, and its atrial appendages are often overlooked even in cardiac anatomy.

These delicate and astonishingly thin structures are challenges for medical device developers.

Some intricate structures within the heart are so thin that a business card can be read through them, said Tim Laske, VP of research and business development for the cardiac ablation solutions business at Medtronic. When observing the heart in a surgical space, it becomes evident that atrial appendages carry blood, emphasizing the ne…