Development of a Novel Angioplasty Catheter for Treatment of Calcified Arteries

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Coronary artery disease is very common, has significant associated morbidity and mortality, and is frequently treated by balloon angioplasty. Coronary artery calcification is highly prevalent in coronary artery disease and poses a significant challenge to angioplasty procedures. In 2012, 1.1 million angioplasty procedures were performed in the US; 38% of which involved moderate to severe calcification. Coronary artery calcification can prevent effective coronary artery dilation during balloon angioplasty leading to incomplete expansion of coronary stents; a well-established risk factor for major adverse cardiovascular events, including stent thrombosis and restenosis. Use of higher balloon pressures to crack the calcification increases the risk of complications and damage to the artery. Extensive coronary artery calcification frequently precludes angioplasty leading to coronary artery bypass grafting; a costlier alternative. Coronary artery calcification increases in prevalence with age and in older patients in which the risks of coronary artery bypass grafting may be prohibitive. We seek to address this unmet need. We have prototyped a novel device capable of delivering impacts of variable frequency and energy to sites of calcification. Such impacts lead to micro-fractures in vascular mural calcification and subsequently enable traditional angioplasty balloon dilation and stenting techniques to proceed unhindered. The proposed solution would enable the interventional cardiologist to render angioplasty in calcified coronary arteries much more predictable and therefore safe. As a standard over-the-wire technology, little additional training would be needed and minimal procedural time required to site, deploy, activate and retreive the device. Induction of micro-fractures within the vascular mural calcium would then allow safe, predictable low-pressure vessel expansion during standard balloon dilation and subsequent stenting. This approach will also potentially allow extension of the indications for angioplasty procedures into populations where calcification is currently deemed too extensive for angioplasty, particularly in the older population where calcific disease has a high prevalence but co-morbidities preclude open heart surgery.