Catheter for Peripheral Vascular Applications Approved
The CiTop Guidewire, manufactured by Ovalum, Limited was approved by the FDA for peripheral vascular applications. Ovalum already received the CE Mark in September of this year. News of the approval was published on the Israel Venture Capital Research Center website.
The company, which is based in Israel, manufactured an intra- coronary non-balloon micro catheter. Included is an alloy tip which is designed to to lock on to the distal tip of the guidewire. This allows controls of the modifying J-shape of the initially created guidewire tip.
These features support optimal stiffness penetration, as well as directional controlled access to the distal and proximal caps. This mitigates the need to change the guidewire during the procedure. This procedure offers advantages over existing approaches, which are limited in treating CTO that is particularly dense.
The product is a single-use device to treat chronic total occlusion (CTO). Obstructions are usually dense and, therefore, a guidewire cannot be passed to remove the occlusion. As a result, treatment with either surgery or complete amputation of the affected area is often required.
Multi-center trials with the device were completed to verify device efficacy and safety to clear arterial blockage. The CiTop was compared to other methods and showed superior efficacy in CTO treatment.
October 30, 2007 Related topics: Product Approval & Certification, New Technology & Innovation, Surgery, Cardiology