TARYAG MEDICAL Ltd.

Post market clinical follow up of Bycross® device.

The aim of the study is to demonstrate safety and effectiveness of ByCross Rotational and Aspiration device used for revascularization of total or sub-total occluded peripheral arterial vessels equal to or larger than 3mm in diameter.
The ByCross is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross can be used in several pathologies: calcified atheroma, old and fresh thrombus.
Eligible adult patients with symptoms due to chronic sub-total and total occlusion will be enrolled and undergo percutaneous procedure including use of ByCross which will normally be followed by balloon inflation (Percutaneous Transluminal Angioplasty) in the artery at location where blockage has been opened by ByCross to further open the artery and restore full opening, and in some case followed by placement of a stent for long term stabilization.
For demonstrating safety and effectiveness up to 42 patients will be enrolled. the procedure will take up to 2 hours followed by up to 48 hour hospitalization. Patients will then come for follow-up monitoring and examination 30 days and 6 months after procedure. Although this is unlikely, in some cases the physician can decide during procedure that following ByCross opening of the artery, ballooning or stent is not required. In this case the patient will come for another follow-up visit after 12 month.