Next-generation Nitinol

Key Milestones of the PRIME Project – From Specification to Clinical Readiness

1. Release of Tube Specifications

   Completed: January 2023

   The project began with the definition of Nitinol tube specifications, forming the foundation for subsequent medical device development. During this phase, technical requirements were defined based on the expertise of contract manufacturers, taking into account stent manufacturing processes, material properties, and product-specific needs. Once all details were aligned, the specifications were finalized and approved by all relevant stakeholders.

2. Test Plan Creation

   Completed: June 2023

   In parallel with ingot and mill product manufacturing, a comprehensive test plan was developed. This plan outlines all standard tests for both tubes and stents, covering various product groups such as heart valve frames, peripheral stents, and neurovascular stents, and includes functional performance requirements.

3. First Bar Delivery

   Completed: July 2023

   The first batch of Nitinol bars was successfully delivered, marking a key milestone in raw material procurement. Upon arrival, the material underwent thorough quality inspection to ensure compliance with the previously defined specifications and standards.

4. First Tube Deliveries

   Completed: March and April 2024

   Following material approval, the first bars were processed via gun drilling to produce the initial batch of tubes. These tubes underwent internal inspections to confirm they met all defined criteria. The first batches were subsequently delivered to the designated manufacturing partners.

5. First Stent Manufacturing and Characterization

   Completed: August 2024

   With tube production underway, the project progressed to the manufacturing and testing of medical device components. The main goal was to verify that the established manufacturing processes were compatible with the new ingot material. The production—covering all steps from material handling to shape setting and surface treatment—ran smoothly, demonstrating stable and reproducible results.
   The manufactured heart valve frames and stents met all predefined quality and performance standards. During this phase, production of subsequent ingots and tube batches continued. Testing was carried out in accordance with the approved test plan, and the results were thoroughly analyzed.

6. Ongoing Tube Deliveries, Testing, and Data Collection

   Status: May 2025

   The 13th tube batch, comprising four different sizes, has been successfully delivered. Two additional batches are currently in production. Manufacturing and testing of the latest four batches are ongoing, with data collection and analysis in progress.