Dive Brief:

• FDA's circulatory system devices panel Tuesday is examining a premarket approval application for Neovasc's device to treat refractory angina pectoris, chest pain caused when the heart muscle is not receiving adequate blood supply.
• The stent-like device, called Reducer, is implanted in a minimally invasive procedure to increase blood flow and is intended to offer a new treatment option for patients who do not respond to medical therapy and are not suited for coronary artery bypass grafting or percutaneous coronary intervention.
• The device gained FDA's breakthrough device designation in October 2018 and has received the CE mark in the European Union. Neovasc submitted a PMA application for Reducer in December 2019. Still, FDA pointed out in pre-meeting materials that pre-clinical and clinical evidence to support the device's mechanism of action is limited.

Dive Insight:

Much is riding on the FDA's ultimate decision for the small Canadian company. Its second quarter revenue plunged 35% to about $284,000, which the company blamed on woes related to the pandemic. It also posted a roughly $8.7 million operating loss in the quarter, deeper than an approximately $6.6 million loss a year earlier.

The advisory panel, which the FDA is not bound by but frequently takes the advice of, will consider available data and make recommendations on the safety and effectiveness of the Neovasc device. 

FDA estimates 1 million Americans may have refractory angina, which restricts a patient's activities and severely impairs quality of life. Other FDA-approved treatments for the condition -- enhanced external counter pulsation and myocardial laser revascularization -- are not widely used, the agency said.

Neovasc's device is implanted in the coronary sinus, which is the large vein that drains the blood from the heart. The device works by modulating the outflow of blood from the heart muscle and redistributing the oxygenated blood into areas of the heart with poor blood supply. Restoration of blood flow to the affected areas relieves the patient's symptoms and improves exercise tolerance and quality of life, according to the company. The procedure is done under local anesthesia using a catheter inserted through a small needle puncture in the jugular vein and takes about 20 minutes to perform.

The company in June released interim results from 241 refractory angina patients in the REDUCER-I study that showed 70% saw improvement in their symptoms through three years by one class on the Canadian Cardiovascular Society grading system, and 34% saw symptom improvement of two CCS classes. 

The data reinforce results of the 2015 COSIRA study published in the New England Journal of Medicine, Neovasc said. That study showed 35% of patients in the treatment group (18 of 52 patients) had improvement of at least two CCS angina classes at six months, compared to 15% of those in the control group.

FDA pointed out potential concerns in an executive summary published ahead of the meeting. "Since the publication of the COSIRA study, important questions regarding the proposed mechanism of action for this device remain. Keeping in mind that an understanding of the Reducer's mechanism of action is not a requirement for PMA approval, the Panel may wish to consider the uncertainties regarding the device's mechanism of action and the scientific plausibility of clinical benefit when assessing the totality of the clinical data."

SVB Leerink analysts, in a note to clients published in August, said the device represents a meaningful market opportunity for Neovasc. FDA's scheduling of a PMA review panel for the device implies that the agency views the existing clinical data as sufficient for approval, the analysts wrote at the time.