Data From Clinical Trial Evaluating Cardiovascular Systems’ Diamondback 360° to Treat Above-the-Knee Peripheral Arterial D...
March 24 2011 - 8:00AM
Business Wire
EMBARGOED UNTIL 9:30 A.M. CT, April 5,
2011
ACC i2 Poster Contributions Session No.
2516 (Poster #507)
WHAT: Principal Investigator Dr. Raymond Dattilo, St.
Francis Health Center, Topeka, Kan., will present preliminary acute
results of the COMPLIANCE 360° study.
The COMPLIANCE 360° is a prospective, randomized multicenter
feasibility study that examines whether the Diamondback 360º PAD
System, by improving lesion compliance through differential
sanding, can achieve satisfactory acute and durable results without
the need for stent placement. In the COMPLIANCE 360° study, 50
patients were enrolled at nine U.S. sites. The Diamondback 360º PAD
System is a minimally invasive orbital atherectomy system indicated
for use as therapy in patients with peripheral arterial disease
(PAD) – blockages in leg arteries.
WHEN: Tuesday, April 5, 9:30 a.m. – 10:45 a.m.
WHERE: Hall F, Ernest N. Morial Convention Center, 900
Convention Center Blvd., New Orleans
THE CV Innovations Educational
Forum
WHAT: Drs. Stevan Himmelstein, Baptist Memorial
Hospital-Desoto, Memphis, Tenn., and Jeffrey Chambers, Mercy
Hospital, Minneapolis will provide an overview of their use of the
Diamondback 360° at the ACC CV Innovations Forum, which features
cutting-edge research and product development. They will discuss
their clinical experience with CSI’s orbital technology for
peripheral and coronary applications, along with highlights of
CSI’s clinical data with an emphasis on small, calcified
vessels.
WHEN: Monday, April 4:
- 9:45 a.m.: Advancing the Standard of
Care for Treating PAD, Dr. Himmelstein
- 10 a.m.: The Future of Coronary
Interventions, Dr. Chambers
WHERE: Exhibit Hall Stage, Ernest N. Morial Convention
Center
ABOUT CSI AND PAD: 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. More than 12
million people in the United States suffer from PAD. With risk
factors such as diabetes and obesity on the rise, the prevalence of
PAD is growing at double-digit rates.
In April 2010, CSI also received FDA unconditional IDE approval
for ORBIT II, a pivotal trial to evaluate the safety and efficacy
of the Diamondback 360° in coronary arteries. A coronary indication
for calcified lesions represents a large, underserved market
opportunity. CSI completed enrollment of 50 patients for Phase I of
the ORBIT II trial. ORBIT II is expected to enroll 429 patients,
subject to FDA review of data from the first 50 cases.
Visit CSI at booth #4458, i2 Summit Interventional Pavilion,
9:30 a.m.-4:45 p.m. Sunday, April 3 or Monday, April 4, or 9:30
a.m.-1:30 p.m. Tuesday, April 5.
INTERVIEW OPPORTUNITIES: Interviews can be requested by
contacting Nancy Johnson, (612) 455-1745 (o), (612) 812-7568 (c)
njohnson@psbpr.com, or Nick Banovetz (612) 455-1705 (o) or (651)
815-5999 (c), Padilla Speer Beardsley.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
interventional treatment systems for vascular disease. For more
information visit the company’s Web site at www.csi360.com.
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