David Planer, MD, Heart Institute, and Amos Cahan, MD, Department of Internal Medicine, Hadassah University Hospital.
Background
Coronary blood flow is driven by a pressure gradient across the heart wall and limited by arterial resistance. Atherosclerosis or increased diastolic intra-ventricular pressure may impair coronary blood flow. Consequently, myocardial function and viability may be compromised.
The Need for Improved Coronary Blood Flow
Major clinical conditions associated with impaired coronary perfusion include:
- Ischemic heart disease, both chronic (stable angina pectoris, intractable angina) and acute coronary syndrome (unstable angina and acute myocardial infarction)
- Systolic heart failure, including cardiogenic shock
- Diastolic heart failure, resulting from cardiomyopathy or ischemia.
Currently practiced management of these conditions includes medications, coronary catheterization and angioplasty, coronary bypass surgery and heart transplantation. Despite the evident clinical benefit of globally increasing coronary blood flow, no such treatment is available for outpatients. An intra-aortic balloon pump may improve coronary perfusion, but its use is restricted to hospitalized patients in intensive care units, limited to a short period of time and associated with potentially lethal complications.
Constantly or intermittently increasing coronary blood flow would potentially have an important clinical role in the management of these patients.
The proposed unique aortic pacemaker may be used as an adjunctive therapy to increase coronary blood flow in outpatients as well as hospitalized patients, with resulting improved survival and quality of life.
Another condition that may benefit from aortic pacing is aortic valve regurgitation, currently treated medically or surgically by aortic valve replacement. The proposed pacemaker may by used to selectively and efficiently block retrograde diastolic blood flow across the incompetent aortic valve and prevent complications such as left ventricular dilatation and failure associated with this condition.
Market
According to the American Heart Association, congestive heart failure (CHF) afflicts approximately 5 million people in the US, and an estimated 550,000 new cases crop up each year.
No aortic pacemakers are currently available in the market. The closest market segment is Implantable Cardioverter Defibrillators (ICSs). As a benchmark, over 100,000 ICDs were implanted in patients in the USA in the year 2002. This number has been growing at approximately 17% annually, and is therefore anticipated to reach almost 262,000 procedures in 2008 in the US, and over 654,000 procedures worldwide. ICD market cap is estimated at approximately $3 Billion in 2005, and anticipated to grow to as high as $5.7 Billion by 2010.
The Innovation
The Aortic Pacemaker selectively paces the aortic media (the muscular layer of the aorta) in a synchronized manner during ventricular diastole to induce its contraction. Such contraction will enable the aorta to pump blood. The device will include a sensing component to detect ventricular diastole, as well as a processing means and a pacing device.
The aortic pacemaker will have several applications such as in acute myocardial infarction, intractable angina pectoris, cardiogenic shock, congestive heart failure and aortic regurgitation.
R&D Program
- Initial prototype build-up
- Initial tests in a closed-circuit system
- Improved prototype build-up for further clinical studies
- Pre-clinical trials
Contact
Stuart Bernstein
Business Development, Medical Devices
Tel: +972-2-6777906
Email: stuart@hadasit.co.il
