FDA Clears Next-Generation Guide Wire For Cardiovascular Systems’ Peripheral Orbital Atherectomy Systems

ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (NASDAQ:CSII) (CSI), today announced that it has received FDA clearance for its new ViperWire Advance^® Peripheral Guide Wire with Flex Tip for their Peripheral Orbital Atherectomy Systems (OAS). 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).

“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.”

Building on the success of the current ViperWire Advance, this next-generation wire offers a reduction in tip stiffness, with comparable torque transfer, making it easier for physicians to navigate vasculature. 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:

• A Nitinol support coil, for a more durable tip and the ability to be reshaped for multiple uses; and
• 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 chief executive officer. “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 2015. The guide wire is for use with CSI’s 145 cm Stealth 360^® and Diamondback 360^® Peripheral OAS.

About Peripheral Arterial Disease (PAD)
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 360^® and Diamondback 360 Peripheral Orbital Atherectomy Systems, minimally invasive catheter systems developed and manufactured by CSI. 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.

Product Disclosure
The Stealth 360^® and Diamondback 360^® Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated 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.

About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. 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. For more information, visit the company’s website at www.csi360.com.

Safe Harbor
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, the statement in this press release regarding the anticipated timing of the launch of the ViperWire Advance with Flex Tip is a forward-looking statement. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, production and marketing timelines and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.