Ovalum Ltd., Announced The First US Procedures Using The Revolutionary CiTop Guidewire System
Miami, FL - Ovalum Ltd. announced the first US procedures using the revolutionary CiTop guidewire system.
The procedures will be performed at the Washington Hospital Center (WHC) in Washington DC by Dr. Nelson L. Bernardo.
Ovalum Ltd., a privately held Israeli medical device company, has received U.S. Food and Drug Administration (FDA) marketing clearance in October 2007 for the CiTop Guidewire system for angiographic procedures in the peripheral vasculature.
This U.S. marketing clearance follows CiTop Guidewire system September approval for CE Marking from the European Economic Area. According to Barry T. Katzen, MD, FACR, FACC, a member of Ovalum Ltd. Advisory Board and medical director of Baptist Cardiac and Vascular Institute in Miami, "Saving limbs is dependent on successful recanalization of total occlusions, frequently in long segments. This device is a simple and effective method in the hands of the physician to improve results in the treatment of total occlusions."
Noam Shamay, founder and Ovalum Ltd. Chief executive officer, said "It is very exciting to have the first procedures in the US; the company is planning to launch the product with the support of the leading US interventional physicians.
We completed our training program structuring and will use 25 luminary sites in the US to participate in the company training program and conduct our post marketing study.
The company is currently building up its distribution channels for the peripheral markets in the US, Europe, Asia and South America. In these markets the launch is planed for the middle of the year.
In light of the promising results we got so far in the coronary study the company is expecting to broaden the device indication of use to the coronary vasculature and to receive regulatory approvals of the coronary indication by mid year."
About Ovalum
Ovalum Ltd. is a privately held medical device company established in 2005 to develop and produce safe and effective technology designed specifically for the most challenging arterial conditions.
The CiTop Guidewire system is a 0.014" high-end guidewire with a dilatable tip specifically designed for CTO recanalization. The CiTop Guidewire is available in both 6gr and 10gr degrees of stiffness, to address the broad range of artery sizes and occlusion hardness present in Peripheral Artery disease (PAD) patients anatomy.
A guidewire is a mandatory tool which provides exclusive access to minimally invasive treatments. In order to use balloon catheters and stent delivery systems minimally, invasive specialists all need a guidewire to cross the lesion first.
CTO have continuously presented some of the more difficult challenges to interventional cardiologists and radiologists.
Ovalum's CTO solution, the CiTop Guidewire system enables the minimally invasive intervention specialist to cross over the arterial blockage in a controllable and reproducible way. The system is made of a highly flexible guidewire body and a distal tip consisting of a working element with dilating capabilities to facilitate wire cross-over.
SOURCE: Ovalum Ltd.