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Cardiovascular Systems Unveils New Data from CONFIRM Study Series at the New Cardiovascular Horizons Conference

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Cardiovascular Systems Unveils New Data from CONFIRM Study Series at the New Cardiovascular Horizons Conference

06/07/2013

Subanalysis of CONFIRM Data Highlights Orbital Atherectomy’s Safety in Treating PAD within Claudicant, CLI, and Renal Disease Patient Populations

  • Plaque modification with orbital atherectomy resulted in similar low procedural complication rates for both patients with and without renal disease
  • Both claudicants and critical limb ischemia patient groups had low rates of procedural events, regardless of arterial calcium burden

ST. PAUL, Minn.--(BUSINESS WIRE)--June 6, 2013--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), unveiled new data from its CONFIRM study series in three poster presentations at the 2013 New Cardiovascular Horizons (NCVH) conference in New Orleans.

“Treatment with CSI’s orbital atherectomy system resulted in low procedural complication rates, whether patients suffered from renal disease or not—indicating that orbital atherectomy is an effective tool for treating PAD, despite the severity of lesion characteristics.”

The CONFIRM study series evaluated the use of CSI’s orbital atherectomy system as a treatment for peripheral arterial disease (PAD)—in above- and below-the-knee lesions—in a real world population of patients (with no exclusions).

Eighty-one percent of the lesions treated had severe or moderate calcification—historically considered a difficult patient population to treat. Patients studied included those suffering from renal disease, claudication (painful circulatory problems), and/or critical limb ischemia (CLI) (the worst form of PAD, caused by chronic inflammation in lower extremities).

CSI posters include:

Pooled Analysis of the CONFIRM Registries: Outcomes in Patients with Renal Disease Treated for Peripheral Arterial Disease with Orbital Atherectomy

Dr. Michael Lee, UCLA Medical Center, Los Angeles, shared data from “Pooled Analysis of the CONFIRM Registries: Outcomes in Patients with Renal Disease Treated for Peripheral Arterial Disease with Orbital Atherectomy.” Results show that plaque modification with CSI’s orbital atherectomy system resulted in similar low procedural complication rates for patients with renal disease, compared to those without, despite having more unfavorable baseline clinical and lesion characteristics.

“Calcified lesions are difficult to treat, and patients with renal disease could have increased complications after peripheral intervention. These hard-to-treat patients have historically been excluded from clinical trials,” said Dr. Lee. “Treatment with CSI’s orbital atherectomy system resulted in low procedural complication rates, whether patients suffered from renal disease or not—indicating that orbital atherectomy is an effective tool for treating PAD, despite the severity of lesion characteristics.”

Orbital Atherectomy Outcomes of the Critical Limb Ischemia Patient Population within the CONFIRM Series

“Orbital Atherectomy Outcomes of the Critical Limb Ischemia Patient Population within the CONFIRM Series,” by Dr. Tony Das, Cardiology and Interventional Vascular Associates, Dallas, Texas, was also shared at NCVH. Approximately 44 percent of patients in the CONFIRM series suffered from CLI, yet the occurrence of procedural complications was low after treatment with CSI’s orbital atherectomy system, regardless of arterial calcium burden.

Orbital Atherectomy Outcomes of the Claudicant Patient Population within the CONFIRM Series

Dr. George Adams, Rex Health Care, Raleigh, N.C., shared data from “Orbital Atherectomy Outcomes of the Claudicant Patient Population within the CONFIRM Series.” Claudicant patients represented 56 percent of patients in the CONFIRM study series, and of those patients, 81 percent had moderate to severely calcified lesions. Orbital atherectomy proved to be a safe tool for restoring blood flow in claudicant patients, regardless of the calcium severity.

“The majority of claudicant patients suffered from moderate-to-severe calcification, yet the occurrence of procedural complications was low after treatment with CSI’s orbital atherectomy system,” said Dr. Adams. “The favorable results demonstrate that orbital atherectomy can effectively treat PAD in claudicant patients, regardless of calcium burden.”

Copyright BusinessWire, Inc., 2013

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