Project: A vascular implant that simplifies anastomosis of blood vessels

-------_x000D_Goal:_x000D_-------_x000D_The long-term goal of this project is to bring a vascular implant to the medical technology market that simplifies the (re-)connection (anastomosis) of tubular organs like blood vessels and nerves. Removing a difficult and time-consuming step occurring in the majority of operations, i. e. the suturing of blood vessels, will reduce operation time and increase the success rate of the surgical procedure. This will ultimately lead to a spread of surgical technology as a whole, affecting the life quality of people worldwide while at the same time lowering the costs associated with the medical treatment. _x000D_To do this, the concept-proven prototype of the implant needs technical refinement and verification in clinical testing in order to meet the requirements of the end-user and the authorities. We therefore propose a collaboration between:_x000D__x000D_1. Prozeo Vascular Implant AB - a Swedish SME, hereinafter referred to as ProzeoVI: _x000D_ R&D of medical implants, technology owner, surgical expertise_x000D_ 2. Sigolis AB - a Swedish SME, hereinafter referred to as Sigolis:_x000D_ Micromachining and thermoplastic injection molding _x000D_ 3. Ensinger GmbH - a German company, hereinafter referred to as Ensinger:_x000D_ Production and packaging of high-performance thermoplastics and medical devices_x000D_ 4. Karolinska Institute - a Swedish medical research institution, hereinafter referred to as KI:_x000D_ Expertise in surgery, potential end-user, experienced in clinical studies_x000D__x000D_If successful, the implant will be ready to market right after conclusion of the proposed project through acquisition of the CE-mark._x000D__x000D_-----------------_x000D_Background:_x000D_-----------------_x000D_The number of surgical procedures performed worldwide is steadily growing whilst becoming more and more advanced. This trend is accelerated by maturation of medical technology in rising economies like China and India. However, despite the recent advantages in medical technology, one essential part reCOed nearly untouched throughout the centuries. The anastomosis of blood vessels is in their majority done by suturing up to this very day. Suturing is a time consuming technique that can take up to 80% of the_x000D_operational time. Even routine operations require highly skilled surgeons for the anastomotic part in order to minimize the risk of post-operative complications. Nevertheless, about 30% of these anastomosis related operations require re-surgery. _x000D__x000D_Prozeo Vascular Implant AB is a spin-off from the Karolinska University Hospital in Stockholm. The vascular implant was invented by Hassan Kansoul, a surgeon specialized in transplantology and general surgery. The vascuring technology has proven its potential to facilitate and standardize anastomosis of blood vessels in two in vivo pilot studies. The implant will not only improve the medical safety and the comfort of the patient, but it will also decrease the costs associated with this type of surgery by decreasing the operational time as well as by lowering the risk for complications. The implant consists of two polymer rings that each adhere to the open ends of the blood vessel. The two parts of the vessel are then connected by simply snapping the rings together. Compared to suturing or clipping this approach is remarkably faster, simpler and moreover, only minimal invasive since the implant does not come in direct contact with the blood circulation._x000D__x000D_------_x000D_Aim:_x000D_------_x000D_The specific aims of this project are to:_x000D_ 1. convert the existing hybrid prototype of the vascular implant into a full-polymer version, _x000D_ 2. verify the product in pre-clinical and clinical tests,_x000D_ 3. obtain the CE- mark to reach marketability, and_x000D_ 4. set up and optimize an industrial process for series production._x000D_

Acronym Vascular Implant (Reference Number: 6331)
Duration 01/09/2011 - 31/01/2014
Project Topic The present project will result in a new kind of vascular implant that simplifies the otherwise difficult to perform anastomosis of blood vessels. This will remove the rate limiting step of most surgical operations, reduce the risk of complications and positively affect the health of the patient.
Network Eurostars
Call Eurostars Cut-Off 6

Project partner

Number Name Role Country
4 Sigolis AB Partner Sweden
4 Karolinska Institute - Department of Molecular Medicine and Surgery Partner Sweden
4 Vascuring AB Coordinator Sweden
4 Ensinger GmbH: Sparte Fertigteile / TZ Partner Germany