Cardiovascular Systems announces first patient enrolled in REACH PVI clinical study

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Cardiovascular Systems recently announced that the first patient has been enrolled 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.

According to a press release, the company’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, interventional cardiologist at the Cardiovascular Institute of the South in Lafayette, USA, enrolled the first patient.

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.”

Lodha continued, “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 chief executive officer, said, “CSI continues to innovate and develop medical evidence to improve the care of patients suffering from PAD. The commercialisation of the Extended Length orbital atherectomy systems and our investment in REACH PVI both demonstrate our commitment to physicians and the patients they serve.”

About REACH PVI
REACH PVI is a prospective, observational, single-arm, multicentre post-market study that will enrol 50 patients at up to 10 sites across the USA. 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).

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