Reflow Spur™ Stent Clinical Trial Concludes Enrollment

Reflow Medical, Inc. has successfully completed enrollment in the DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Spur™ Stent. This innovative device is designed to provide stent-like results while leaving no permanent metal behind.

The study enrolled 130 patients across 35 clinical centers in the United States. The high enrollment rate and support from numerous centers highlight the significant unmet need for effective treatment options for critical limb-threatening ischemia (CLTI).

The Spur Stent is the first Retrievable Scaffold Therapy (RST) that features a retrievable stent with radially self-expanding spikes. This design allows for the treatment of diseased vessel walls without leaving any permanent implants.

Lead Principal Investigators, Dr. S. Jay Mathews and Dr. Mahmood K. Razavi, expressed excitement about the potential benefits of the device based on promising clinical data from previous trials.

The DEEPER REVEAL study aims to assess the efficacy and safety of the Spur Stent in treating vascular lesions in the infrapopliteal arteries below the knee. The study’s findings will support the company’s efforts to obtain U.S. approval for the device.

Reflow Medical, Inc. is committed to providing innovative solutions for cardiovascular disease treatment. The Reflow portfolio includes products for treating both coronary and peripheral vascular diseases, empowering physicians to offer effective and less invasive care to patients.

Source link: http://www.businesswire.com/news/home/20240509783534/en/Reflow-Medical-Completes-Enrollment-in-the-DEEPER-REVEAL-Clinical-Trial

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.