Behind and Below the Knee with Diamondback 360(R) System
“Reaching full enrollment is a significant step in the CALCIUM 360° trial, one of several studies completed or in progress, that reflect our commitment to providing clinically useful data to patients, their families and their physicians,” said David L. Martin, president and CEO of Cardiovascular Systems. “There is a strong need for safer, more effective and durable treatment options for treating hardened plaque behind and below the knee.”
The CALCIUM 360° trial is comparing the effectiveness of the Diamondback 360° to balloon angioplasty in treating atherosclerosis in the smaller vessels behind and below the knee (popliteal, tibial and peroneal). The study enrolled 50 patients at eight investigational sites and is following patients for 12 months. Interventional cardiologists and vascular surgeons are participating in the study. The primary endpoint is 30 percent or less residual stenosis, or plaque remaining, with no major dissection. In addition to collecting clinical outcomes, the CALCIUM 360° study will gauge the economic utility of both the Diamondback 360° and angioplasty procedures and subsequent hospitalizations.
“As the first randomized study in this field, CALCIUM 360° will provide useful, clinically significant data on the treatment of below-the-knee lesions,” said Dr. Jihad Mustapha, an interventional cardiologist at Metro Health Hospital, Grand Rapids, Michigan, who enrolled the most patients in this trial. “Patients with multiple below-the-knee occlusions have traditionally had little hope of salvaging a limb. I have used the Diamondback 360° to modify plaque and restore blood flow in many patients who had been scheduled for amputation.”
CALCIUM 360° is part of CSI’s 360° Clinical Series to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360° System. The COMPLIANCE 360° feasibility study, currently under way, is another study in the series that is prospectively evaluating 50 patients treated with either the Diamondback 360° or angioplasty in above-the-knee arteries. These studies complement the already completed OASIS and OASIS Long Term studies that demonstrated the safety, effectiveness and durability of the Diamondback 360° device in treating peripheral vascular disease.
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are intended to enjoy the protection of the safe harbor for forward-looking statements provided by that Act. For example, the statements in this press release regarding CSI’s expectation that the CALCIUM 360° study will provide useful, clinically significant data on the treatment of below-the-knee lesions is a forward-looking statement. These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the potential for unanticipated delays in enrolling medical centers and patients for the study; new data or events that may disrupt plans for this study; unexpected results or clinical outcomes in the CALCIUM 360° study and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K. 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.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., (CSI) (Nasdaq: CSII) based in St. Paul, Minn., is a medical device company focused on providing clinically proven, safe and effective interventional solutions for vascular disease. The company’s Diamondback 360(R) System removes calcified and fibrotic plaque in small and large peripheral vessels, and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD (peripheral arterial disease), and CSI commenced a U.S. product launch in September 2007. Since then, more than 25,000 procedures have been performed using the system. For more information visit the company’s website at www.csi360.com.
The Diamondback 360(R) System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The system is 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.
SOURCE: Cardiovascular Systems, Inc.
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