DMC Cardiovascular Institute is among the first in the region to offer a new treatment option to people suffering from the debilitating effects of blocked coronary arteries caused by Coronary Artery Disease – the Diamondback 360° Coronary System. 

Cardiologist Theodore Schreiber, M.D., President of DMC Cardiovascular Institute, has played a pivotal role in demonstrating the potential safety and effectiveness of this new technology and its ability to provide new hope for treating the disease.  

Coronary Artery Disease (CAD) is a life-threatening condition where a fatty material called plaque builds up on the inside walls of the key arteries in the circulatory system. The build-up of plaque causes the arteries to harden and narrow – a condition called atherosclerosis – reducing blood flow.

Over 17 million people in the US alone suffer from CAD, making it the most common form of heart disease in the nation. It accounts for more deaths than any other major cause of death in the U.S., claiming more lives than cancer, chronic lower respiratory diseases and accidents combined, according to the American Heart Association.  

As one of the pioneering physicians dedicated to exploring medical advances to improve the odds for patients with CAD, Dr. Schreiber believes that the new Diamondback 360° system may offer lifesaving benefits. “This system optimizes the ability to remove plaque and restore flow for treating CAD – ultimately improving the patient’s quality of life and saving lives,” Dr. Schreiber said.

FACT SHEET: Diamondback 360° Coronary System Fact Sheet

Technology Overview
The Diamondback 360^® Coronary System is specially designed to remove calcific and fibro-calcific plaque in blocked coronary arteries, thereby facilitating effective stent placement and restoring blood flow to the heart. The device has an eccentrically mounted, diamond-coated crown that comes in four sizes: 1.25, 1.50, 1.75 and 2.00 mm. It is mounted on a 145 cm long catheter (Figures 1, 2) that is thread over and spins on the proprietary ViperWire™ Guide Wire.

The system operates on the principles of centrifugal force. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion or plaque, removing a small amount of plaque with each orbit.

The catheter is used with an external control unit (“controller”), which provides the system controls and user interface. A constant flow of normal saline solution, delivered by a roller pump in the control unit, lubricates the device and helps to flush the artery during treatment.

The Diamondback 360° Coronary System has a unique mechanism of action called differential sanding which discriminates between compliant arterial tissue and hardened plaque (including diseased fibro-calcific or calcific plaque). Compliant tissue flexes away from the crown as it passes (Figure 4). Diseased calcific and fibrotic plaque is not compliant and provides resistance, allowing the orbiting crown to sand the plaque (Figure 5). That plaque becomes minute particles that are absorbed by the body.

Coronary Artery Disease
Coronary artery disease (CAD) is the most common form of heart disease in the U.S., affecting more than 17 million people each year. It accounts for more deaths than any other major cause of death in the U.S. and claims more lives than cancer, chronic lower respiratory diseases and accidents combined. (American Heart Association Heart Disease & Stroke Statistics. 2010)

CAD is treated with coronary artery bypass graft (CABG) surgery in more than 400,000 people each year in the U.S. In this open-chest surgery, a segment of a healthy blood vessel from another part of the body is used to make a detour around the blocked part of the coronary artery. Hospital stays last 4 to 6 days or longer.

Minimally invasive treatment with percutaneous coronary intervention (PCI) accounts for more than 1,300,000 procedures each year. PCI is a procedure in which a catheter (a thin, hollow tube) is threaded through the blood vessels and is used to deliver a device to the heart to treat the artery blockage. Patients can frequently return home the same day of the PCI procedure or may need to stay in the hospital one night. The most common PCI treatments are:

Balloon angioplasty – A procedure where a tiny balloon on a tip of a catheter is inserted in the artery blockage and inflated, pressing the plaque of the blockage against the artery wall and opening the artery.

Stenting – A procedure where a wire mesh tube is placed within the blockage that acts like a scaffolding to keep the artery open.

Atherectomy (such as Diamondback 360°) – The process of removing the plaque that is blocking the artery.

Combination of all of the above.

A Potential New Treatment Option for Severely Calcified CAD
Patients with severely calcified CAD may benefit from treatment with the Diamondback 360°, which sands away the hardened (or calcified) plaque blocking the artery. Removing the hardened plaque may make it safer and easier for the physician to place a stent and thus restore blood flow to the heart muscle. In some patients, this treatment may take the place of heart bypass surgery, an open-heart procedure.

Also Treating Peripheral Arterial Disease
The peripheral version of the Diamondback 360° System has previously received U.S. FDA granted 510(k) clearance for use as a therapy for PAD (peripheral arterial disease). CSI commenced a U.S. product launch in September 2007, and since then, more than 35,000 lower-extremity procedures in more than 700 hospitals have been performed nationwide. For more information, visit www.csi360.com.