NICE guidelines announce guidance supporting the use of Neovasc Reducer
The National Institute for Health and Care Excellence (“NICE”) has recommended the use of Neovasc Reducer™ System in suitable patients with refractory angina. This is a breakthrough for refractory angina patients, many of whom experience debilitating chest pain as alternative treatment options have failed or are not a viable option.
NICE’s recommendations focus on the psychological impact of patient’s pain. This recommendation is a positive step forward in improving patient outcomes, as NICE has previously not supported any therapeutic interventions in the treatment of refractory angina.
The placement of the Reducer is a transvenous procedure performed in the Cardiac Catherisation lab which takes approximately 20 minutes with limited post procedure side-effects.
In accordance with NICE guidelines, “Coronary sinus narrowing device implantation is indicated for people in whom other treatment options (medical or surgical) have failed or are not possible (refractory angina). The aim is to reduce symptoms and to improve quality of life.”
Dr. Jonathan Hill, MD, Consultant Interventional Cardiologist at Royal Brompton Hospital, London, U.K., commented, “The NICE committee that evaluated the coronary sinus narrowing device extensively reviewed the available clinical data regarding the Reducer device. Today’s guidance document is good news for patients in the United Kingdom suffering from refractory angina that haven’t had treatment options supported by NICE guidance.”
Nathan Pettitt, Group General Manager at Healthcare 21 commented “Today is a fantastic day for our cardiovascular team at Healthcare 21, Neovasc and most importantly patients across the UK. Our team has worked tirelessly to launch the innovative Neovasc Reducer™ system in the treatment of refractory angina. Our partnership with Neovasc Inc. is an important one and this NICE recommendation will ultimately result in continued application of the Neovasc Reducer™ and ultimately improved outcomes for patients across the UK.”
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing.
The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure and is completed in approximately 20 minutes.
While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the Reducer in October 2018. This designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: neovasc.com.
About Healthcare 21
Healthcare 21 is the exclusive distributor for Neovasc Reducer in England, Scotland and Wales.
Healthcare 21 aim to assist clinicians in improving outcomes for their patients and clients by providing leading worldwide products supported by continuing education programmes to ensure optimum use for healthcare professionals.
Healthcare 21 is a subsidiary of the AddLife AB Group. Headquartered in Stockholm, AddLife is a Swedish medical technology company listed on the Nasdaq Stockholm, Mid Capital stock market since 2016. AddLife has in excess of 55 subsidiary companies, predominantly in mainland Europe in niche segments in the life sciences sector, from research to healthcare.
Healthcare 21 are an innovative and leading provider of sales, marketing, distribution, and service solutions to healthcare organisations throughout Ireland, UK and Germany.
Healthcare 21 specialises in 15 therapeutic segments including: cardiovascular, critical care, endoscopy, surgical, GI interventions, scientific and laboratory, imaging, medical supplies, pharmaceuticals, primary care and rehabilitation, acute capital, wound care and compression, specialist medical, orthopaedics as well as technical services.
Healthcare 21 achieved sales in excess of €155M. The company has 450 employees and is headquartered in Cork, Ireland.