Neovasc recruits first patient in refractory angina treatment trial

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The Neovasc reducer (Image by Neovasc)

Neovasc (NSDQ: NVCN) today announced that it has enrolled the first patient in the Cosira-II clinical trial for its Neovasc reducer.

The pivotal Cosira-II trial (Coronary Sinus Reducer for the Treatment of Refractory Angina) by Neovasc, based in Vancouver, Canada, will investigate the safety and effectiveness of the reducer in reducing symptoms of angina. chest in people with intractable angina.

Study results will complement existing international data on safety and efficacy, and support Neovasc’s application for pre-market approval (PMA) from the FDA to market, according to a press release. the Reducer device in the United States.

Neovasc designed the Cosira-II trial as a randomized, double-blind, placebo-controlled study that will enroll approximately 380 patients at no less than 50 investigation sites in the United States and Canada. The study has a primary endpoint defined as the change in duration of the exercise tolerance test measured at six months via a treadmill test.

The first patient in the trial was recruited from St. Francis Hospital & Heart Center (Roslyn, New York) under the direction of Dr Ziad Ali and Principal Investigator Dr Evan Shlofmitz. The patient has a history of chronic refractory angina pectoris and has already undergone several cardiac catheterization procedures for treatment, none of which has been successful in relieving his chest pain.

“We are delighted to launch Cosira-II and grateful that the Centers for Medicare and Medicaid Services have determined that the device and procedure are eligible for reimbursement in the United States during the clinical trial,” said Fred Colen, CEO of Neovasc, in the press release. “Determining coverage is a big win for us. Cosira-II is a major investment for the company.

“We are grateful to our staff and investigators for their hard work to finalize all required deliverables on time, such as FDA approval, local hospital review board approval, qualification processes , on-site training, and all contracts and legal documents required by completion. of 2021, allowing this first registration. The finalization of the reimbursement rate for the trial procedure will allow Medicare beneficiaries who are eligible for the trial to have better access. “

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