News | Heart Failure | September 27, 2019

Positive Safety, Efficacy Data Reported on AccuCinch Heart Failure Device

Interim study results from systolic heart failure patients treated with percutaneous therapy designed to improve left ventricular function presented at TCT 2019

Positive Safety, Efficacy Data Reported on AccuCinch Heart Failure Device

September 27, 2019 — Ancora Heart Inc. announced results from an interim analysis of heart failure patients treated in the CorCinch FMR study, a U.S. early feasibility study. CorCinch FMR evaluated the safety of the investigational AccuCinch Ventricular Repair System designed for the treatment of systolic heart failure. The data was presented at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, Sept. 24-29 in San Francisco.

The latest available analysis of the first 31 heart failure patients with functional mitral regurgitation treated with the AccuCinch system at leading heart centers across the United States was presented by Satya Shreenivas, M.D., interventional cardiologist at The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital.

“Early safety and efficacy data on the transcatheter AccuCinch system is impressive and suggests the therapy has the potential to repair the left ventricle, improve heart function and restore the quality of life for heart failure patients,” said Shreenivas. “Notably, the results from patients at six-month follow-up indicates heart function improves over time. These initial results are highly promising and demonstrate AccuCinch’s potential to address many of the shortcomings of current heart failure therapies.”

Data from the interim analysis indicate a favorable safety profile with 97 percent freedom from device-related major adverse events at 30 days. Preliminary efficacy data from the first nine patients treated with the latest implantation technique and with adjudicated core lab data available through six months demonstrated a reduction in left ventricular volume by an average of 23 percent. Ejection fraction, a measure of blood flowing out of the left ventricle, improved on average from 31 percent to 39 percent over the same period. Additionally, Kansas City Cardiomyopathy Questionnaire scores increased by an average of 30 percent, suggesting reducing the left ventricular volume resulted in improved quality of life and reduced heart failure symptoms for this group. Further, mitral regurgitation grades and regurgitant volumes were both substantially reduced across this cohort.

Enrollment in the CorCinch FMR study recently concluded and 35 patients were treated with the AccuCinch at 15 heart centers. The primary safety endpoint of the study is device-related or procedure-related major adverse events through 30 days. Secondary exploratory endpoints include technical success, device and procedural success, as well as other observational endpoints measuring heart function, heart failure symptoms and changes in quality of life.

The transcatheter AccuCinch therapy is designed to complement and enhance the existing care cardiologists provide to further manage symptoms and slow, or stop, the progression of heart failure. For some patients, AccuCinch may have the potential to reverse the enlargement of the left ventricle. For patients where heart failure has progressed beyond the ability for medications and pacemakers to manage symptoms, non-surgical percutaneous device therapy with AccuCinch may provide an effective treatment option. The AccuCinch system is designed to directly repair the left ventricle of the heart, thereby addressing the fundamental issue in the progression of systolic heart failure.

For more information: www.ancoraheart.com

Related Content

A 3-D rendering created from the chest CT scan of a 41-year-old coronavirus patient in China showing ground-glass opacities in several areas of the lungs from the coronavirus pneumonia. This was from one of the first medical imaging studies published on COVID-19 in the journal Radiology. #coronavirus #COVID2019 #COVID19 #2019nCoV

A 3-D rendering created from the chest CT scan of a 41-year-old coronavirus patient in China showing ground-glass opacities in several areas of the lungs from the coronavirus pneumonia. This was from one of the first medical imaging studies published on COVID-19 in the journal Radiology. 

Feature | Cardiovascular Clinical Studies | February 20, 2020 | Dave Fornell, Editor
February 20, 2020 — The American College of Cardiology (ACC) released a
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Overlay Init