Boris Varshitzky, MD, Morris Mosseri MD, and Chaim Lotan, MD, Heart Institute, Hadassah University Hospital and Nachum Borivker, Eng.
Background
A variety of lesions may occur related to atherosclerosis, including aorto-ostial lesions. Ostial lesions are defined as those arising within 3mm of the origin of a blood vessel. Aorto-ostial lesions damage the ostium of the main blood vessels branching from the aorta. When dealing with aorto-ostial lesions, the treatment outcome using such conventional treatments has been limited by a low success rate and high incidence of restenosis, or recurrence of artery blockage. Coronary stenting is an attractive alternative for this subset of lesions.
The main problem in implementing coronary stents is to determine the exact position for the stent. Limited visualization of the coronary artery ostium, angulations of the aorto-coronary segment and difficulties in the placement of the guiding catheter are all factors that affect the final result. If situated too proximally, stent protrusion into the aortic lumen interferes with aortic blood flow and hastens further aortic catheterization. If situated too distally, the desired aim of scaffolding the ostial lesion is missed. In addition, there is the potential to compromise the lumen and subject the patient to a higher incidence of sub-acute stent thrombosis or restenosis, as well as a high risk for dissection, acute closure or rupture.
Only a comprehensive approach, taking into account all technical aspects of PCI, can serve as a firm basis for devising a novel stent delivery system with the use of a stent locator.
Market
The potential target population consists of 90% of renal artery interventions (~250,000 procedures annually worldwide) and 5-7% of coronary revascularization procedures (~150,000 procedures annually worldwide). The total stent market is currently valued in excess of $6b. No device currently exists on the market to aid in the correct placement of stents at aorto-ostial lesions.
The Innovation
We have developed a comprehensive approach for accurate stent positioning. This approach comprises a flexible position device attached to a guide catheter for a typical inflatable balloon outfitted stent. The stent locator is adapted to change its shape prior to making contact with the interior wall surface of a major blood vessel in the ostial region of a smaller blood vessel branching off from said major vessel. Moreover, the stent locator possesses mechanical means for changing its shape wherein this change enables the locator to abut the interior wall surface ensuring correct apposition between the stent and the ostium of the smaller blood vessel.
The main purpose of the stent locator system is for use in significant stenosis of the aorto-ostial segment such as the right coronary artery, left main, grafts and renal artery. Further uses of this technology may also include significant stenosis of all branches arising from the aorta or the other main vessels. Current use of Percutaneous Transluminal Coronary Angioplasty to aorto-ostial lesion has been associated with reduced procedural success and a high recurrence rate. Technical difficulties using current technology, such as proper seating of the guiding catheter, obtaining adequate images, ensuring proper stent position, and preventing stent migration during balloon inflation, is overcome with the new stent locator technology.
R&D Program
Proof of concept has been achieved in an animal study. The next stage is to produce a 2nd generation prototype and advance to further animal trials and use in humans.
Contact
Stuart Bernstein
Business Development, Medical Devices
Tel: +972-2-6777906
Email: stuart@hadasit.co.il
