Nitinol: History, Capabilities, and Advancements

Nitinol has recently gained significant attention within the medical device industry due to its superelastic and shape memory properties, which make it an ideal alloy for various applications. Many Medical Device OEMs are incorporating Nitinol into their medical device portfolios. But how did this unique alloy achieve its current status, and what does the future hold for next-generation advancements? Confluent Medical Technologies' history and direct involvement in the development of Nitinol provide valuable insights into these questions.

Confluent’s History in Nitinol

Confluent Medical Technologies, originally known as Nitinol Device and Components (NDC), was founded in 1991 by Tom Duerig, a renowned leader in the medical use of Nitinol. Recognizing Nitinol's unique benefits for medical device applications, Duerig developed some of the first Nitinol laser-cut stents. Since 1997, Confluent’s experts have contributed to creating standards related to Nitinol in the medical field and have consulted with the FDA to establish guidance documents for its use.

In 2003, Confluent developed Hypotube, the first process to draw Nitinol into tubing. This process was further advanced in 2017 with the development of Precision tubing. 

As the use of Nitinol expanded in the medical field, there arose a need for a higher-purity form of the alloy. In 2011, Confluent collaborated with ATI to develop the first high-purity implant-grade material called ELI, which remains one of the purest forms of Nitinol used in medical applications today. Nitinol.com offers more insight into Confluent’s history of investments and innovation within the Nitinol space.

Confluent’s Nitinol Capabilities

Nitinol's superelastic and shape memory properties make it an ideal alloy for components in the structured heart, electrophysiology, neurovascular, interventional pulmonology, and peripheral vascular markets. Confluent offers a range of Nitinol contract manufacturing capabilities, from simple wireform devices to complex laser-cut designs. Their state-of-the-art manufacturing facilities are equipped to bring even the most challenging devices to market.

Confluent’s Nitinol component capabilities include:

• Nitinol material production (wire, tube, strip, mill)
• Laser machining
• Laser welding
• Profile and surface grinding
• Burr-free cutting
• Deburring
• Forming/shape setting
• Stamping
• Electropolishing and passivation
• Surface treatment
• Machining

Confluent’s Nitinol Component in-house services include:

• Design services
• Finite element analysis
• Transformation temperature tuning
• Mechanical properties testing
• Radial force and crush testing
• Fatigue testing and analysis
• Corrosion testing
• Failure analysis

In addition to industry-leading Nitinol component capabilities, Confluent is the only supplier with direct control over a vertically integrated Nitinol supply chain. This ensures security, flexibility, and best-in-class lead times for customers. Recent investments in this critical supply chain have enhanced Confluent’s ability to secure availability for component manufacturing with rapid prototyping lead times of 2 weeks or less.  

With over 60 lasers, 33 manufacturing lines, 500 dedicated employees to Nitinol production, and over 100 years of combined Nitinol engineering experience, Confluent stands behind its statement, “WE ARE NITINOL” and is proud to be the industry’s most trusted experts in Nitinol.

Confluent’s Advancements in Nitinol

Inclusions within a component can be points of fracture initiation if located in high-strain areas. To mitigate these inclusions, Confluent offers SE508 ELI, a high-purity implant-grade material ideal for high-fatigue applications such as cardiovascular implants or small-feature components like neurovascular stents.

The CT Scan images below show a Nitinol tubing cross-section comparison of ASTM Standard Inclusion Rate vs Confluent’s SE508 ELI.

Confluent remains at the forefront of advancements in processes, materials, and technologies for medical-grade Nitinol. Currently, the company is focused on developing next-generation high-purity materials to facilitate lower-profile and more durable implants. Additionally, Confluent is enhancing laser technologies to improve precision and manufacturing efficiency while implementing the latest inspection technologies for Nitinol components.

For over 30 years, Confluent’s expertise has led the Nitinol industry in design, manufacturing, testing, and advancements in Nitinol components and materials. From developing some of the first laser-cut Nitinol stents to becoming the only supplier with a reliable, vertically integrated Nitinol supply chain, Confluent has paved the way for Nitinol in the Medical Device industry. As Nitinol's popularity continues to rise and new technological advancements emerge, Confluent remains committed to being the most trusted partner in bringing current and future medical devices to market.