Welcome

Welcome to VascoCure - Your partner for engineering services in the field of medical implants

We support you in all project topics with a focus on product and process development for cardiovascular implants such as stents, stent grafts, heart valves, occluders, and more, especially using the shape memory alloy Nitinol.

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Our services cover the entire spectrum of product development, starting from concept, through simulation and testing, to final implementation. With a strong emphasis on precision and quality, we offer customized solutions for product and process development to ensure that your requirements and standards are met.

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Viktor Heit, owner of VascoCure - Medical Engineering Service, is an experienced mechanical engineer with extensive expertise as a project manager for medical implants. He has worked in several reputable and innovative technology companies and now contributes his expertise under his own name.

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What sets us apart:

• Expertise in the design and development of stents and other medical implants made from Nitinol

• Comprehensive experience in project work from idea to market launch according to applicable standards in the medical field

• Customized solutions for individual requirements and the highest quality standards

• Dedicated collaboration, transparent communication, and timely implementation

• Long-standing experience in a specialized field, providing the highest flexibility with minimal onboarding time and independent work style

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Trust in our expertise and contact us today to elevate your project to the next level!

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The following list provides an excerpt from international norms and standards in the field of cardiovascular implants and serves as the basis for our work:

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• DIN EN ISO 13485:2021-12: Medical devices - Quality management systems - Requirements for regulatory purposes

• ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

• ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

• ISO 25539-3: Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters

• ASTM F2514: Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

• ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

• ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

• ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

• ASTM F2079: Elastic Recoil of Balloon-Expandable Stents

• ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices.

• FDA Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. April 18, 2010

• Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. August 18, 2015

• FDA Guidance for Industry and FDA Staff: Reporting of Computational Modeling Studies in Medical Device Submissions. September 21, 2016

Heart Valves:

• ISO 5840-3: Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques

• ISO 5910: Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices