News | July 14, 2009

First Patient Enrolled in Trial Evaluating Treating Above the Knee PAD With Diamondback 360° System

July 14, 2009 – Cardiovascular Systems Inc. (CSI) said yesterday the first patient has been enrolled in its COMPLIANCE 360° clinical trial, a prospective, randomized study to generate additional data on patient outcomes achieved in treating lesions above the knee with CSI’s Diamondback 360° Peripheral Arterial System, a minimally invasive catheter for treating peripheral arterial disease (PAD).

COMPLIANCE 360° will compare the benefits of first modifying calcified plaque with the Diamondback 360° system followed by low-pressure balloon inflation if needed, as compared to the use of high-pressure balloon angioplasty alone in calcified lesions above the knee. Treatment with only high-pressure balloon angioplasty often damages large diseased vessels above the knee. Initial treatment with the Diamondback 360° could reduce the level of balloon pressure required to finish opening the vessel. The COMPLIANCE 360° study calls for enrolling 50 patients at five U.S. medical centers. Patients will be followed for 12 months, and an independent angiography core lab will verify results.

CSI received FDA 510(k) marketing clearance for the Diamondback 360° as a PAD therapy in August 2007 on the basis of data from the OASIS study, a prospective study which enrolled 124 patients at 20 medical centers. Since then, nearly 500 hospitals have adopted the Diamondback 360° system, the company said.

“The Diamondback 360° represents a viable treatment option for patients who previously have had limited options,” said Ravish Sachar, M.D., an interventional cardiologist at WakeMed Health and Hospital in Raleigh, N.C., who enrolled the first patient in the COMPLIANCE 360° trial. “Treating this disease can be very challenging due to the frequency of non-compliant, calcified plaque resulting from diabetes, smoking or renal failure. It has long been understood that high-pressure balloon angioplasty alone in these types of lesions can lead to vessel damage, and this study will help provide insight into the benefits of plaque modification prior to angioplasty.”

For more information: www.csi360.com

Related Content

News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD)| August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI).

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI). This image shows how the covered stents used with the system connect to create a new arterial pathway.

News | Peripheral Artery Disease (PAD)| August 02, 2017
Aug.
Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon
Technology | Drug-Eluting Balloons| July 26, 2017
The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market approval (PMA) of the...
First European Patient Enrolled in Intact Vascular's TOBA II BTK Trial
News | Stents Peripheral| July 26, 2017
Intact Vascular Inc. recently announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Artery Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter
News | Chronic Total Occlusion (CTO)| June 28, 2017
June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus...
Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System
News | Peripheral Artery Disease (PAD)| June 26, 2017
Shockwave Medical recently announced two milestones for its Lithoplasty System for the treatment of calcified plaque in...
Overlay Init