VANCOUVER and MILAN, Oct. 22, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced today that the Neovasc Reducer (Reducer) was featured in multiple presentations during the symposium A Proven Evidence-based therapy when Angina Persists, held this month at the National Congress of the Italian Society of Interventional Cardiology (GISE) in Milan, Italy.
A prestigious team of key opinion leaders reviewed the latest results of the Reducer Therapy. The highlights showed that 50% of the patients improved by 2 CCS Classes or more while 83% of patients improved by 1 CCS Class or more. Seventeen percent (17%) did not respond to the therapy. Additionally, the average CCS score decreased from 3.2 to 1.7 (p<0.001). Putting together this data with the significant dissatisfaction with current therapies, gives us tremendous excitement for the potential for Reducer in the market place, said Professor Shmuel Banai, MD, Medical Director, Neovasc.
In selected presentations:
Prof Shmuel Banai, Director, Division of Cardiology Tel-Aviv Medical Center, and Neovasc Medical Director, presented the history and rationale of coronary sinus narrowing for the treatment of angina. In 1948, American Cardiac Surgeon, Claude Schaffer Beck, developed an effective treatment for patients with disabling angina by creating a surgical narrowing of the coronary sinus. Between the years 1948 to 1964 Dr. Beck successfully used this procedure on more than 1,000 patients with coronary heart disease. In 1952, Dr. Beck became the first to receive the title of professor of cardiovascular surgery in the United States. More recently, Neovasc developed non-surgical methods to narrow the coronary sinus in Europe and Canada. These methods proved effective, enhancing blood supply to the ischemic heart, increasing quality of life and protecting the heart while reducing infarct size.
Pr. Sergio Berti, Fondazione Toscana G. Monasterio, based on recent survey data of clinical cardiologists in the Milan area, reinforced that many patients suffer from angina despite optimal therapy. The clinical cardiologists polled estimate that as many as 12% of their angina patients are refractory to currently available therapies. On average, these physicians each had 20 such patients, of which approximately 50% were not satisfied with their current therapy. Physicians confirmed they would likely have sent these patients for a definitive interventional treatment, if they were aware of such a therapy. The conclusion of the survey was that there are still many patients with refractory angina, who are not satisfied with their quality of life or their current therapy, and who could potentially benefit from the Reducer. These leading cardiologists reinforced that the suffering of patients has a significant impact on their everyday life. As a measure of that, these patients on average return for a consultation on a monthly basis.
Dr. Francesco Giannini, GVM Care & Research Maria Cecilia Hospital Cotignola, reviewed the technical and procedural aspect of the Reducer Therapy. During his presentation, Dr. Giannini reinforced the strong safety profile of the procedure.
On behalf of the investigators, Dr. Gianpiero DAmico, University of Padua, presented the Italian Society of Interventional Cardiology (GISE) Multi-Center study on the Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina. One hundred eighty three patients suffering from severe refractory angina were treated with coronary sinus narrowing by Reducer implantation in 16 medical centers across Italy. Presented data demonstrated a 98% technical success rate. Efficacy data at median follow-up of 564 days showed significant improvements in angina severity with minimal rates of complications. Results, based on the Canadian Cardiovascular Society Class (a measure of the severity of angina) (CCS Class), showed that 50% of the patients improved by 2 CCS Classes or more, 83% of patients improved by 1 CCS Class or more and 17% did not respond to the therapy. The average CCS score decreased from 3.2 to 1.7 (p<0.001). Quality of life as assessed by the Seattle Angina Questionnaire (SAQ) also improved significantly across all 5 domains (p<0.001). Data comparing the CCS Class improvement results of the Italian registry to seven other previously published Reducer studies demonstrated consistent results across all studies.
Finally, the current President of GISE, Pr. Giuseppe Tarantini, University of Padua, reinforced the importance of the new European Society of Cardiology guidelines for the Reducer Therapy and the importance of this therapy for patients who currently have few treatment options.
"We are delighted that another significant independent study of real-world data continues to support the extensive body of clinical evidence for the efficacy of the Reducer, said Fred Colen, President and Chief Executive Officer of Neovasc. We have a clear call to action supporting the physician community, and in particular the general cardiologists, to inform the many patients who are suffering from angina. The Reducer may be a new, safe and symptom-improving option. We continue to be actively engaged with the U.S. Food and Drug Administration (FDA) and we have completed another informative discussion earlier this month. This new data from Italy will be presented in our ongoing discussions with the FDA as we work for regulatory approval for the Reducer in the United States.
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: http://www.neovasc.com.
About ReducerThe 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 in the heart's circulatory system, thereby 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 that is similar to implanting a coronary stent 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 for 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. 1
1T. J. Povsic, S. Broderick, K. J. Anstrom et al., "Predictors of longterm clinical endpoints in patients with refractory angina," Journal of the American Heart Association, vol. 4, no. 2, article e001287, 2015.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words "expect", "anticipate", "estimate", "may", "will", "should", "intend," "believe", and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, statements regarding the potential benefits to the Reducer as a result of many refractory angina patients not being satisfied with their quality of life or current therapies, that there may be a new, safe and symptom improving option in the Reducer, the future approval for the Reducer in the United States, the growing cardiovascular marketplace and the growing incidence of refractory angina. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three and six months ended June 30, 2019 (copies of which may be obtained at http://www.sedar.com or http://www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Go here to read the rest:
- Interventional Cardiology Fellowship - Massachusetts General Hospital ... - April 8th, 2018 [April 8th, 2018]
- Dr. Eric Lo - Daytona Beach FL, Interventional Cardiology - April 18th, 2018 [April 18th, 2018]
- Interventional Cardiology | Cardiology Associates of East ... - April 19th, 2018 [April 19th, 2018]
- ECU Interventional Cardiology Fellowship - May 26th, 2018 [May 26th, 2018]
- Interventional Cardiology | Knoxville Heart Group - June 6th, 2018 [June 6th, 2018]
- Interventional Cardiology Fellowship - Massachusetts ... - June 14th, 2018 [June 14th, 2018]
- Scottsdale Interventional Forum | Cardiology Conference ... - June 21st, 2018 [June 21st, 2018]
- Interventional Cardiology - Terumo Europe - August 12th, 2018 [August 12th, 2018]
- Interventional Cardiology Fellowship | Cardiovascular Fellowship - September 20th, 2018 [September 20th, 2018]
- Interventional > Cardiovascular Medicine | Internal Medicine ... - September 20th, 2018 [September 20th, 2018]
- Interventional Cardiology Journal | Peer reviewed Journal - September 24th, 2018 [September 24th, 2018]
- Interventional Cardiology | North Florida Regional Medical ... - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Department of Medicine ... - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Medical City Fort Worth - October 4th, 2018 [October 4th, 2018]
- Cardiology and Interventional Cardiology | Texas Tech ... - October 4th, 2018 [October 4th, 2018]
- Invasive & Interventional Cardiology Section | Cleveland Clinic - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology - Crozer-Keystone Health System - PA - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology - Florida Medical Clinic - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Heart Hospital of New Mexico - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | ColumbiaDoctors - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiologist Jobs | Glassdoor - October 4th, 2018 [October 4th, 2018]
- What are Invasive, Non-Invasive, and Interventional Cardiology? - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology Fellowship | Internal Medicine - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Community Health Network - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Ohio State Medical Center - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Stanford Health Care - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology - Montefiore Medical Center - November 10th, 2018 [November 10th, 2018]
- Interventional Cardiologists near Brooklyn, NY - Healthgrades - November 10th, 2018 [November 10th, 2018]
- Cardiac Catheterization | Interventional Cardiology in New ... - November 20th, 2018 [November 20th, 2018]
- What are Invasive, Non-Invasive, and Interventional ... - November 27th, 2018 [November 27th, 2018]
- Dr. Jaffar A Raza - Secaucus NJ, Interventional Cardiology - November 30th, 2018 [November 30th, 2018]
- Interventional cardiology - Wikipedia - December 13th, 2018 [December 13th, 2018]
- Interventional Cardiology | St. Francis - December 21st, 2018 [December 21st, 2018]
- Interventional Cardiologists near Secaucus, NJ - Healthgrades - December 21st, 2018 [December 21st, 2018]
- Interventional Cardiology Conferences & Meetings - December 25th, 2018 [December 25th, 2018]
- Interventional Cardiology - Baylor Heart and Vascular Hospital - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiology - nationwidechildrens.org - January 18th, 2019 [January 18th, 2019]
- General & Interventional Cardiology - WakeMed - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiology - University of Mississippi Medical ... - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiologists in Austin, TX | Austin Heart - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Sutter Health - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology - St. Mary's Hospital and Health ... - February 22nd, 2019 [February 22nd, 2019]
- London & Milan - Cardiology Fellowships - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Saint Luke's Health System - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | American Medical Association - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Piedmont Heart Institute ... - March 12th, 2019 [March 12th, 2019]
- Interventional Cardiology | UCSF Cardiology - March 18th, 2019 [March 18th, 2019]
- If You Are Referred to an Interventional Cardiologist - April 1st, 2019 [April 1st, 2019]
- Cardiology and Interventional Medicine | Veterinary ... - April 5th, 2019 [April 5th, 2019]
- Interventional Cardiology | AdventHealth Cardiovascular ... - May 11th, 2019 [May 11th, 2019]
- APSIC - Asian Pacific Society of Interventional Cardiology - May 13th, 2019 [May 13th, 2019]
- Interventional Cardiology | UNC REX Healthcare | Raleigh ... - May 20th, 2019 [May 20th, 2019]
- Interventional Cardiology - montefiore.org - May 20th, 2019 [May 20th, 2019]
- Women and heart health: Heart attack signs and symptoms to know about - The Indian Express - September 26th, 2019 [September 26th, 2019]
- Tiara for Treatment of Mitral Regurgitation and Neovasc Reducer for Treatment of Refractory Angina to be Featured at TCT 2019 Conference - Canada... - September 26th, 2019 [September 26th, 2019]
- TherOx to Present on SuperSaturated Oxygen (SSO2) at TCT2019 Next Week - BioSpace - September 26th, 2019 [September 26th, 2019]
- Too tired? it can indicate heart failure - The New Indian Express - September 26th, 2019 [September 26th, 2019]
- Blue Sail Medical and Biosensors International enter the Structural Heart market with the acquisition of Switzerland based NVT AG. content= - PR... - September 26th, 2019 [September 26th, 2019]
- Global Diagnostic Interventional Cardiology Instruments Market forecast by 2025 : Numerous tactics accepted by industry participants in a bid to... - September 26th, 2019 [September 26th, 2019]
- UMA's Complete Conference Management Hosts "Full Spectrum of Heart Failure Therapy: Optimizing Outcomes" - Yahoo Finance - September 26th, 2019 [September 26th, 2019]
- Meet the best cardiologists at King's Interactive Heart Health Morning - Gulf News - September 26th, 2019 [September 26th, 2019]
- Lights, camera, action in Varnville - Bluffton Today - September 26th, 2019 [September 26th, 2019]
- Health Pro: Cardiologist takes pleasure in getting patients back on their feet - Florida Today - September 26th, 2019 [September 26th, 2019]
- From Ceiling Suspension to Eye-Tracking: Innovation Continues for Cath Lab Radiation Protection - TCTMD - September 26th, 2019 [September 26th, 2019]
- Robocath Successfully Carries Out Its First Robotic Coronary Angioplasties in Humans - TCTMD - September 26th, 2019 [September 26th, 2019]
- SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in ABIOMED, Inc. of Class Action Lawsuit and Upcoming... - September 28th, 2019 [September 28th, 2019]
- Study links childhood obesity with screen time - The Hindu - September 28th, 2019 [September 28th, 2019]
- Tiara for Treatment of Mitral Regurgitation and Neovasc Reducer for Treatment of Refractory Angina to be Featured at TCT 2019 Conference - BioSpace - September 28th, 2019 [September 28th, 2019]
- Five Atlantic Health System Team Members Lauded by NJ American Heart Association for Life-Saving Measures - TAPinto.net - September 28th, 2019 [September 28th, 2019]
- World Heart Day 2019: Cardiovascular Disease Is The World's Biggest Killer And Claims More Than 17.5 Million Lives - Outlook India - September 28th, 2019 [September 28th, 2019]
- Consulting Cardiologists Brings Exceptional Care to Heart of WH - Patch.com - September 28th, 2019 [September 28th, 2019]
- Diagnostic Interventional Cardiology Devices Market 2019| Global Forecast to 2026 with Key Players- B. Braun Medical, Boston Scientific, Cook Medical,... - September 28th, 2019 [September 28th, 2019]
- Surmodics Inc. (SRDX) and Its Competitors Comparing side by side. - MS Wkly - October 17th, 2019 [October 17th, 2019]
- Global Price, Sales and Revenue Analysis of Diagnostic Interventional Cardiology Devices Market by Regions, Manufacturers, Types and Applications -... - October 17th, 2019 [October 17th, 2019]
- Global Interventional Cardiology Devices Market Study by Price, Type and Application, Statistical Forecast and Competitive Landscape Research upto... - October 17th, 2019 [October 17th, 2019]
- Global Interventional Cardiology Market Report, Trends, CAGR Standing, Analysis and Forecasts (2019-2025) | Key Companies BIOTRONIK SE & Co.... - October 17th, 2019 [October 17th, 2019]
- Interventional Cardiology Market 2019 to Flourish with an Impressive CAGR of XX% in the year 2024, Predicts Market Research Future According to... - October 17th, 2019 [October 17th, 2019]
- FDA Approves Coronary ViperWire Advance With Flex Tip - Diagnostic and Interventional Cardiology - October 23rd, 2019 [October 23rd, 2019]
- Teleflex Announces Third Quarter 2019 Earnings Conference Call Information Live Webcast is scheduled at 8:00 am (ET) on Thursday, October 31, 2019 -... - October 23rd, 2019 [October 23rd, 2019]
- Global Interventional Cardiology Devices Market Analysis and CAGR during the Forecasting years of 2019-2025. - Air News Paper - October 23rd, 2019 [October 23rd, 2019]