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Cardiovascular Systems Releases New Peripheral Data at 2014 TCT Conference

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Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII) , unveiled new data about the treatment of arterial calcification at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D.C. Arterial calcium is a common occurrence for the millions of patients suffering from peripheral artery disease (PAD) and it can lead to significant complications. Calcified plaque is estimated to be present in approximately 65 percent of the population treated annually for PAD.

Results from the company’s Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study, a prospective, single-arm, non-randomized feasibility study of 25 patients were featured. TRUTH evaluated the removal of plaque with CSI’s Peripheral Orbital Atherectomy System (OAS) by analyzing changes in plaque volume and composition via an independent virtual histology (VH) – intravascular ultrasound (IVUS) core laboratory.

In a poster presentation on Saturday, Sept. 13, 2014, at the Walter E. Washington Convention Center, physicians Anvar Babaev, M.D., PhD (NYU Medical Center, New York City), Susanna Zavlunova, M.D. (NYU Langone Medical Center, New York City), Michael J. Attubato, M.D. (New York University School of Medicine, New York City) and Akiko Maehara, M.D. (Cardiovascular Research Foundation and Columbia University Medical Center, New York City) highlighted TRUTH study results demonstrating that OAS treatment is effective at reducing and modifying calcium from lesions, resulting in low acute complications and improved Rutherford Classification – the scale which measures arterial blockage severity.

Key TRUTH results included:

  • All patients were asymptomatic two weeks after OAS treatment (Rutherford Classification (RC) of 0 (100% asymptomatic) compared to a baseline RC of 3 (96.0%);
  • 100% freedom from recoil, slow flow/no reflow, flow-limiting dissections or perforations after OAS treatment;
  • At the treated lesion site, the minimum lumen area increased significantly from 4.0 mm^2 to 9.1 mm^2 post-treatment (p <0.0001), accompanied by a decrease in area stenosis;
  • At the site of maximum calcium removal, calcium reduction was responsible for 86% of the lumen area increase; and
  • Calcium modification was directly related to OAS usage.

David L. Martin, CSI’s President and Chief Executive Officer, said, “TRUTH demonstrates that by using CSI’s peripheral atherectomy systems, physicians can improve procedural success in calcified lesions. The study also highlights the unique capabilities of our orbital technology and CSI’s commitment to providing physicians new options for treating the most difficult patients.”

About Peripheral Artery Disease (PAD)
As many as 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque 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 is growing at double-digit rates. 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, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

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 for the treatment of PAD 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, over 157,000 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.

Product Disclosure:
The Stealth 360(R) PAD System, Diamondback 360(R) PAD System and Predator 360(R) PAD System 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 and distal.

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