Development of suture-replacing NiTinol implant and a delivery device for TAVI procedures for Novogate Medical.

Surgical Tools & Implants
Surgical Tools & Implants
Surgical Tools & Implants
Surgical Tools & Implants
Transcatheter Aortic Valve Implantation (TAVI) is a catheter-based technique to replace a diseased aortic valve, involving implantation of a valve bio prosthesis deployed within the native aortic valve. (TAVI) can be performed either transfemoral or via a transapical access site.

The Transapical (TA) access – first described in 2006, is considered to be more invasive than vascular approaches, but offers a very good control of the delivery system, a favorable implantation angle, allows precise fine adjustments during the implantation of the valve, prevents contact of the delivery system with the aorta and provides the possibility to accommodate larger sheaths.

Suturing has been traditionally employed in order to secure the apical access site for the introduction of the stent-valve delivery systems and later to seal the access site at the end of the procedure. Such sutures are called "purse-string suture". The suturing and closure procedure requires a lot of experience and if done incorrectly, may lead to a severe blood loss and even death.

As a result – suturing is performed only by lead surgeons, and is considered the most critical part of the procedure.

The Wisefix system is a soft tissue approximation of cardiac apical tissue during trans-catheter valve replacement procedures.

It is comprised of a uniquely designed NiTinol implant which mimics the Purse String suturing technique and a fast deployment controlled-release delivery tool.

Developing a NiTinal implant for the heart and a delivery device

  • Measure and mimic the forces and tissue contraction movement according to current suturing method
  • Utilize a biocompatible super-elastic NiTinol material
  • Develop and manufacture a heart simulator for lab tests
  • Perform lab testing on beating hearts using a simulator and participate in pre-clinical trials
  •  Promising initial results in clinical trail
  • Conceptualization
  • Mechanical design
  • Prototyping and 3D printing
  • Mechanical assembly and integration
  • Clean room class 7
  • One stop shop from concept to serial production
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