…the CiTop™ was successful with an excellent result
Rehovot , Israel (PRWEB) July 11, 2008
Following First-in-Man study success, Ovalum Ltd. launches a multicenter study using the CiTop™ technology in the coronary arteries.
Ovalum Ltd., a privately held Israeli medical device company, has announced today successful experiences using CiTop™ ExPander™ Guidewire in traversing chronic total occlusions in the coronary arteries.
Chronic Total Occlusion (CTO) is one of the main challenges that Interventional Cardiologists face today. Attempts in opening coronary CTOs by using mechanical wires are ranging from 26% to 85% and are operator dependent. In order to increase success rate and make it less operator-dependent, the CiTop™ ExPander™ Guidewire was designed. The CiTop™ ExPander™ Guidewire is a 0.014" Guidewire which combines conventional guidewire navigational properties with a tip dilation feature to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions.
The company has completed successfully its First-in-Man study in the use of the CiTop™ ExPander™ Guidewire in the coronary arteries. Dr. Keyur H. Parikh, The Heart Care Clinic/Care Cardiovascular Consultants (Ahmedabad, India), Principle Investigator of the study has said: "Ovalum with its CiTop™ wire has discovered an approach to a safe and sure way to cross CTOs. Chronic Total Occlusions is one of the last frontiers of the Cardiologists, the CiTop™ wire has shown me an approach towards that last frontier.... "
Ovalum is launching this July its Multicenter study to evaluate the performance of the CiTop™ ExPander™ Guidewire in crossing CTOs in the coronary arteries. Dr. Farrel Hellig from the Sunninghill Hospital in Johannesburg, South Africa, has concluded that "…the CiTop™ was successful with an excellent result" after an initial experience with the CiTop™ ExPander™ Guidewire.
The company has submitted the CiTop™ ExPander™ Guidewire to its notified body in the European Economic Area and is expecting to receive its CE marking during the fourth quarter of 2008. In addition, the company has completed the CiTop™ ExPander™ Guidewire 510K application to the FDA which will be submitted next month.
The CiTop™ ExPander™ Guidewire provides a simpler and more efficient means to open the Chronic Total Occlusion, thus avoiding the need for coronary bypass surgery. Noam Shamay, founder and CEO of Ovalum Ltd. said: "I am enthusiastic about the opportunity to introduce a significantly less invasive therapeutic option for coronary CTO patients".
Ovalum Ltd. was founded in March 2005 by Noam Shamay and Eitan Finkelstein. Located in Rabin Science Park Rehovot, Israel, OVALUM Ltd. Develops, manufactures and markets breakthrough products for the minimally invasive cardiology and interventional radiology markets designed specifically for the most challenging arterial procedures.
Ovalum Ltd. investors: Ziegler Meditech equity Partners LP and Smithfield Fiduciary LLC, represented by Eitan Machover (Director) and Pontifax LP represented by Tomer Kariv (Director).
CiTop™, CoBra™, TraVerse™ are all trademarks of Ovalum Ltd.