Novel Percutaneous Valve Repair System (BIDMC 1058)

Category:    Medical Devices

KeyWords:  Vascular/Thrombosis;  Surgery;  

BIDMC ID:    1058

Abstract:

BACKGROUND: Aortic valve stenosis is a severe narrowing of the aortic valve that ensures unidirectional blood flow from the pumping chamber of the heart to the rest of the body leading to low blood pressure, chest pain and heart failure. The disease affects up to 20% of the elderly and results in 150,000 aortic valve open-heart surgeries annually in this high risk population. Many patients, however, are not candidates for open heart valve surgery as their risk of death due to age and other medical conditions (lung disease and renal failure) is too high. Such patients often die from heart failure and require multiple hospitalizations with a high cost to society and the health care system. Minimally invasive approaches to valve replacement in our aging population are necessary and have been a recent focus of attention in this area. The catheter-based valves mounted on a balloon-expandable stent designed thus far, however, are extremely large and bulky limiting their use and safety in this patient population. INVENTION: A novel catheter-based valve assembly (consisting of animal tissue or synthetic material) is described here whereby multiple smaller parts are utilized allowing for a significantly safer procedure. Specifically, three smaller long stents are delivered via two leg arteries and one arm artery through catheters measuring no more than 2.6 mm. The three stents are positioned together in the valve orifice and deployed simultaneously. The valve is assembled from these three stented leaflets as if it were a three component space station.

Inventor:   Roger Laham, MD

Commercial Opportunity:

Competitive Advantages:

• Smaller profile allows less vascular complications • Improved deliverability with smaller and more flexible stents, limiting risk of stroke and damage to cardiac structures • Longer anchoring component reducing risk of valve migration • Variable geometry possible as needed • Suitable for replacement of any vascular valve: aortic, mitral and other valves

Related Publications:

State of Development:

Prototype device has been tested in 4 healthy pigs demonstrating safety and feasibility. A more standardized three-component prototype for preclinical and first-in-man testing is presently being designed.

Related Technology URL:

http://angiogenesis.bidmc.harvard.edu/default.htm     http://research.bidmc.harvard.edu/research/ResearchPIInfo.ASP?Submit=Display&PersonID=378

Patent Status:

US and foreign applications pending

TVO Contact Info:
     Catherine M Lenich
     Senior Associate TVO
     clenich@bidmc.harvard.edu
     Phone: 617-667-0568   Fax: 617-667-0646

     Beth Israel Deaconess Medical Center
     Technology Ventures Office  Room: BR-0200
     330 Brookline Avenue
     Boston, MA 02215