Neovasc Establishes Direct Sales Operations for Reducer Device in the United Kingdom

July 5, 2022—Neovasc, Inc. announced that the company has expanded its direct sales operations in Europe to include the United Kingdom, effective July 1, 2022. The company has hired its first two direct employees in England and plans future growth in the sales team as the commercial requirements increase.

According to the company, the decision to move to a direct sales operation in the United Kingdom was driven by the Neovasc Reducer being granted national reimbursement in England after inclusion in the most recent High-Cost Tariff Excluded Devices national catalogue, which was announced in June 2021. Hospitals can order the Reducer and bill the cost of the device directly to NHS England.

Also, the company advised that in 2021, the United Kingdom’s Interventional Procedures Program at the National Institute for Health and Care Excellence (NICE) issued guidance supporting the implantation of the Reducer in appropriate patients with refractory angina. Neovasc announced the NICE guidance in November 2021.

As noted in the company’s press release, the guidance document states, “Coronary sinus narrowing device implantation is indicated for people in whom (1) other treatment options (medical or surgical) have failed or (2) are not possible. The aim is to reduce symptoms and improve quality of life.”

Professor Jonathan Hill, MD, an early pioneer in the development of Reducer therapy, commented in the press release, “An important next step in the widespread use of the therapy is a robust program of training and proctoring. We are looking forward to the support of Neovasc’s direct operation in the United Kingdom in training new operators and centers and allowing them to offer the Reducer therapy for all their indicated patients.” Prof. Hill is a consultant interventional cardiologist at Royal Brompton & Harefield NHS Foundation Trust in London, United Kingdom.

The Reducer device has received CE Mark approval in the European Union for the treatment of refractory angina. The Reducer is not approved for commercial use in the United States, but it has been granted Breakthrough Device designation by the FDA, advised Neovasc.

In January 2022, Neovasc announced enrollment of the first patient in the pivotal COSIRA-II clinical trial, which will complement existing international safety and effectiveness data and support a premarket approval application to the FDA for the Reducer device in the United States.