TORONTO – Refractory angina is estimated to affect up to 1.8 million Americans, with 50,000 to 100,000 new cases per year and no readily available device to stem the chest pain and return patients to normal physical activities. All that began to change in 2017 when Fred Colen came on board as president and CEO of Neovasc Inc., which has developed the Reducer – a product hampered at the time by Neovasc’s dismal financial outlook.

“I looked at it and said ‘Wow, this financing is really, really bad,’ and I didn’t know if the company was going to make it,” Colen told BioWorld. “But then I looked at the Tiara and Reducer products and I was blown away by both. I really believed these products had to get to market.”

It’s all about back pressure

Patients who suffer the worst effects of refractory angina occupy Classes 3 and 4 on the Canadian Cardiovascular Society (CCS) angina grading scale, ranging from an inability to walk more than one or two blocks or climb a flight of stairs without chest pain to the capacity to carry on any physical activity without discomfort.

The results of Reducer 1, an international, three-arm observational study of an initial 241 patients with refractory angina were remarkable, Neovasc COO Bill Little told BioWorld.

“At six months follow up all the way out to two years follow up, 70% of patients suffering from the most debilitating angina classes 3 and 4 fell to 15.9%. That was a dramatic impact on really desperate patients who had tried everything else.”

Angina pain occurs when diseased coronary arteries and smaller vessels block the passage of oxygen to the heart, vessels that remain resistant to conventional stents or bypass surgery. The Reducer is implanted in the largest vein of the heart, the coronary sinus, where it reduces the vein’s diameter and modulates the outflow of blood.

What happens next, Little explained, is similar to placing your thumb over the end of a running garden hose. “Like the garden hose which swells up a little bit we’re creating back pressure in these micro-vessels of the heart. This allows for redistribution of blood flow bringing healthy oxygen to portions of the heart that weren’t getting it.”

More oxygen means less ischemic pain for heart patients and eventually greater mobility. Other positive results from the Reducer 1 study: a 91% reduction in emergency room visits in patients transplanted with the Reducer, with 1% of patients experiencing a device or procedure related major adverse event.

Waiting on the panel

What helped Vancouver, British Columbia- and Minneapolis-based Neovasc get the Reducer to this stage was the U.S. FDA breakthrough device designation in October 2018. The public company now hopes to take another giant step following its announcement July 9 of an impending review of the study by a circulatory system devices panel. It will assess the FDA premarket approval application for the Reducer and render a verdict on October 27.

Colen acknowledged that despite hundreds of millions of dollars spent over ten years of R&D and 11% sales growth year over year the company has yet to turn a profit. However, its strength, he declared, remains a US$40 million company valuation and a one-of-a-kind medical device. “There is no competition for this device,” said Colen.

All of which has his colleague, Bill Little, urging interventional cardiologists to stay tuned for the FDA’s response in October to the circulatory system devices panel findings and to recommendations of others. “This really gives the FDA an opportunity to hear all about the device from physicians and patients, statisticians and experts,” said Little. “We’re excited about that and look forward to discussions with the FDA.”

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