Cardiovascular Systems Inc. Enrolls First Patient in REACH PVI Clinical Study

Cardiovascular Systems Inc., a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, has enrolled the first patient in the REACH PVI study. The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy via transradial access for the treatment of peripheral artery disease (PAD) in lower extremity lesions.
 
CSI’s low profile, 5Fr, Extended Length Diamondback 360 Peripheral Orbital Atherectomy System (OAS) and Extended Length Stealth 360 Peripheral OAS are the only atherectomy devices that allow radial access for the treatment of peripheral lesions.
 
National Primary Investigator for REACH PVI, Ankur Lodha, M.D., interventional cardiologist, Cardiovascular Institute of the South, Lafayette, La., enrolled the first patient.
 
Dr. Lodha said, “When endovascular intervention is necessary, PAD lesions are mostly treated through femoral artery access. However, many PAD patients could benefit from faster ambulation time post procedure that radial artery access offers. In addition, some patients may have comorbidities, such as obesity, that complicate or preclude femoral access. The benefits of radial access for percutaneous peripheral vascular interventions are well documented. We believe this study will demonstrate that many of these known benefits, such as low complication rates, high cost effectiveness, and short time to ambulation, can be achieved using orbital atherectomy to treat lower limb PAD lesions through radial access.”
 
Scott Ward, CSI chairman, president, and CEO, said, “CSI continues to innovate and develop medical evidence to improve the care of patients suffering from PAD. The commercialization of the Extended Length orbital atherectomy systems and our investment in REACH PVI both demonstrate our commitment to physicians and the patients they serve.”
 
REACH PVI is a prospective, observational, single-arm, multi-center post-market study that will enroll 50 patients at up to 10 sites across the United States. The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy via transradial access for treatment of peripheral artery disease (PAD) in lower extremity lesions. The study will include CSI orbital atherectomy devices FDA-cleared for treatment of PAD. All subjects will be followed post-procedure through the first standard of care follow-up visit (7-45 days post-procedure).
More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT03943160.
 
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 OAS treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360 Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over 450,000 of CSI’s devices have been sold to institutions worldwide.