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Empowering Medical Innovation

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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.

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.

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.

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

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

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:

  • 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

Contact

Viktor Heit (Owner)

          info@vascocure.com

          +49 (0) 1525 65 33 886

          www.linkedin.com/in/viktorheit

  • LinkedIn

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VascoCure Viktor Heit
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