ST. PAUL, Minn. & NEW ORLEANS--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today announced that 12-month cost-comparison data from its COMPLIANCE 360° study will be presented at the New Cardiovascular Horizons 13th Annual Conference in New Orleans, June 6–9, 2012.
Data will be shared demonstrating the effectiveness of CSI’s Diamondback™ Orbital Atherectomy System in treating peripheral arterial disease (PAD). Studies point toward potentially fewer adverse effects and freedom from restenosis with CSI’s system. Additionally, data shows lower dissection rates, reduced bail-out stenting and less vessel disruption, which preserves treatment options in the future.
NCVH Abstract Discussion:
Orbital Atherectomy Below-the-Knee
WHAT: Dr. Jihad Mustapha, Interventional Cardiologist, Metro Health Hospital, Wyoming, Mich., will present orbital atherectomy below-the-knee data.
Critical Limb Ischemia (CLI) patients frequently present with severely calcified tibial stenoses, resulting in starvation of blood flow to the feet, continuation of limb pain at rest, and exacerbation of non-healing wounds. These small, below-the-knee arteries are challenging to treat, and often a precursor to amputation. Endovascular treatment with the Diamondback Orbital Atherectomy System may have advantages in modifying calcified lesions to allow lower pressure adjunctive balloon, less need for bailout stenting and improved patient outcomes. This presentation will concentrate on the system’s unique method of operation which combines centrifugal force with differential sanding, prevents vessel wall damage and preserves the media, leading to better, more durable outcomes. The abstract will also highlight a case study utilizing the orbital technology for below-the-knee treatment.
WHEN: Thursday, June 7, 2:30 p.m.
NCVH Abstract Discussion:
Cost-consequence Comparison of Orbital Atherectomy vs. Percutaneous Transluminal Angioplasty for Treatment of Calcified Femoropopliteal Lesions: Results from a Multicenter, Randomized Clinical Study
WHAT: Dr. Barry Weinstock, Interventional Cardiologist, Orlando Regional Medical Center, Winter Park, Fla., will present 12-month cost-effectiveness data.
The COMPLIANCE 360° trial is a prospective, randomized study that examines whether CSI’s Diamondback Orbital Atherectomy System can achieve satisfactory acute and long-term results without the need for stent placement in lesions above the knee. In the COMPLIANCE 360° study, 50 patients were enrolled at nine U.S. sites. The Diamondback System is a minimally invasive orbital atherectomy system indicated for use as therapy in patients with PAD – blockages in leg arteries.
Data comparing economic factors such as procedure hospital charges, procedure length, length of stay, and stent and balloon utilization will be reviewed in evaluating orbital atherectomy versus percutaneous transluminal angioplasty at twelve months.
WHEN: Saturday, June 9, 7:12 a.m.
CSI Lunch Symposium
WHAT: Industry thought leaders will share their expertise on topics associated with PAD during a lunch symposium hosted by CSI. The symposium, titled “Fighting the Challenges of Complex Calcium with Simple Physics,” will cover complications of calcium, unique challenges for treating patients with CLI, changing compliance for optimal outcomes, safety, efficiency and cost effectiveness in office-based lab settings.
WHEN: Friday, June 8 12:00 p.m. – 1:00 p.m.
WHERE: Preservation Hall, Studio 7 – 8
New Orleans Marriott, 555 Canal Street, New Orleans
CSI Booth at NCVH: June 6–9, 2012
Attendees can visit CSI at booth #216, 9:00 a.m. – 4:00 p.m. Wednesday, June 6 through Friday, June 8, and 9:00 a.m. – 1:30 p.m. Saturday, June 9.
PAD is a life-threatening condition where a fatty material called plaque builds up on the inside walls of the blood vessels that carry blood from the heart to legs and arms. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD increases if a person has one or several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or personal history of heart disease, heart attack or stroke. PAD affects an estimate 8-12 million in the United States. The disease prevalence increases with age and 12-20 percent of Americans age 65 and older (4.5 to 7.6 million) suffer from PAD symptoms. As the U.S. population ages, the prevalence range could reach 9.6 to 16 million in those age 65 and older and 19 million overall by 2050.
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 Diamondback Orbital Atherectomy System treats calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and addresses 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 August 2007. To date, more than 66,000 PAD procedures have been performed using CSI’s technology in leading institutions across the United States. CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.
For more information, visit the company’s website at www.csi360.com.