Cardiovascular Systems Inc. Gets FDA OK for New Guide Wire System for Peripheral Artery Disease

Cardiovascular Systems Inc. received U.S. Food and Drug Administration (FDA) clearance for its new ViperWire Advance Peripheral Guide Wire with Flex Tip for the firm’s Peripheral Orbital Atherectomy Systems (OAS).

According to the company, the new guide wire provides physicians with improved flexibility, navigation and ease of use—particularly in hard-to-reach, tortuous vessels—when treating arterial calcium associated with peripheral artery disease (PAD).

The next-generation wire offers a reduction in tip stiffness, with comparable torque transfer, making it easier for physicians to navigate vasculature, officials said. The guide wire also provides improved trackability through tortuous peripheral arteries.

Additional features and enhancements of the ViperWire Advance Guide Wire with Flex Tip include anitinol support coil, for a more durable tip and the ability to be reshaped for multiple uses, and a larger proximal core, for improved kink resistance and more delivery support for adjunctive devices.

“We designed the ViperWire Advance with Flex Tip to improve ease-of-use for our peripheral orbital atherectomy systems when treating complex calcified lesions,” said David L. Martin, CSI president and CEO. “By improving the predictability and deliverability of the guide wire, physicians will now have more confidence in their ability to navigate tortuous peripheral anatomy and address PAD in a traditionally difficult-to-treat patient population.”

CSI anticipates launching ViperWire Advance with Flex Tip in early August. The guide wire is for use with CSI’s 145 centimeter Stealth 360 and Diamondback 360 Peripheral OAS, minimally invasive catheter systems developed and manufactured by CSI.

According to figures cited by the company, as many as 18 million Americans, most over age 65, suffer from PAD, which is caused by plaque accumulation in peripheral arteries—commonly the pelvis or leg—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 continues to grow.

Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360and Diamondback 360 Peripheral Orbital Atherectomy Systems. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue—a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates in calcified lesions, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

Cardiovascular Systems is based in St. Paul, Minn. The FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 200,000 of CSI’s devices have been sold to leading institutions across the United States.