Cardiovascular Systems Releases the 2.00 Max Crown

Cardiovascular Systems Inc. (CSI) has released its 2.00 Max Crown for Peripheral Orbital Atherectomy Systems (2.00 Max Crown) to the worldwide market.

“The full commercial launch of the 2.00 Max Crown represents another important product launch for CSI as we broaden and diversify our product offering,” CSI President and CEO Scott R. Ward said. “Our peripheral orbital atherectomy systems can now treat a wider range of plaque morphologies throughout the leg. Combining this new device with our full line of interventional support devices, we continue to advance the ability of physicians to improve outcomes for patients undergoing peripheral interventions.”
 
Built on the Diamondback 360 Orbital Atherectomy platform, the 2.00 Max Crown is designed to enable simultaneous modification of both intimal and medial calcium. The new 2.00 Max Crown features an increased 70-micron diamond coated crown that creates more efficient engagement in mixed plaque, helping to achieve optimal luminal gain in mild to moderately calcified lesions above the knee.
 
Amit Srivastava, M.D., at Bay Area Heart Center in St. Petersburg, Fla., was one of the first physicians in the U.S. to incorporate the 2.00 Max Crown into his practice. “The new 2.00 Max Crown greatly expands the lesions that can be treated with CSI’s Orbital Atherectomy. This device delivers exceptional luminal gain in mixed morphology lesions above the knee,” he said.
 
Eighteen million to 20 million Americans, most over age 65, suffer from peripheral artery disease (PAD), caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
 
Based in St. Paul, Minn., CSI develops and commercializes solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. 
 
* The 2.00 Max Crown has not been tested to support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).