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# FDA OK’s Neovasc IDE for Reducer Device Trial
- URL: https://www.fdaweb.com/fda-oks-neovasc-ide-for-reducer-device-trial/
- Published: 2021-09-17T12:00:00.000Z
- Updated: 2026-09-14T17:15:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150171

FDA has approved a Neovasc IDE for the company to begin the COSIRA-II IDE clinical trial later this year for its Reducer device and its use in treating certain patients with refractory angina pectoris. The company says the trial is designed to address issues raised during a 10/2020 FDA Circulatory System Devices Advisory Panel meeting, which voted 13 to 3 against recommending PMA approval for the Reducer ([see earlier story](https://www.fdaweb.com/device-panel-votes-down-neovascs-reducer/)).

At the panel meeting, several committee members agreed with FDA reviewers that more data are needed before approval could be granted, especially long-term data on safety and effectiveness. An agency [briefing document](https://www.fda.gov/media/143204/download?ref=fdaweb.com) noted that the company provided limited data from three animal studies performed using the current device along with a prior model. The studies provided preliminary information and it “raised concerns regarding the quality and consistency of the data, the level of documentation, unclear timelines, and concerns regarding the degree of tissue coverage and endothelialization of the Reducer device,” it said.

The Reducer comprises an implantable device pre-mounted on a balloon catheter delivery system. It is designed to establish a narrowing in the coronary sinus, which is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina, FDA said at the time. Device implantation is performed through percutaneous access through the right internal jugular vein into the coronary sinus.

According to Neovasc, the COSIRA-II trial’s primary endpoint is the change in exercise tolerance testing time via a modified Bruce protocol between baseline and six-month follow-up. The study is planned to enroll about 380 patients at up to 50 sites in the U.S. as well as limited sites outside the country.