Cardiovascular Systems, Inc. announced the full market release of the 2.00 Max Crown for Peripheral Orbital Atherectomy Systems (2.00 Max Crown). Built on the proven Diamondback 360® Orbital Atherectomy platform, the 2.00 Max Crown is uniquely 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.

Eighteen to 20 million Americans, most over age 65, suffer from PAD, which is 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. The Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series, which includes the Max, Solid, Classic and Micro crowns, is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. Contraindications for the system include for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.

Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm. The 2.00 Max Crown has not been tested to support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).