TEWKSBURY, Mass. /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the first Japanese patients were randomized in Toyama and Hyogo under a clinical trial authorization from the Pharmaceutical and Medical Device Agency (PMDA) in the REDUCE LAP-HF II trial. The Corvia InterAtrial Shunt Device (IASD®) is the world’s first transcatheter device for treatment of heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction.
“We are very proud to be the first hospital in Japan to randomize patients in the trial. Currently, there are limited treatment options for patients suffering from heart failure with preserved and mid-range ejection fraction and I am encouraged by the positive outcomes the Corvia IASD has provided in previous clinical studies.”
– Professor Koichiro Kinugawa, M.D., University of Toyama Hospital
His heart team randomized the first patient at the University of Toyama Hospital.
Professor Masanori Asakura from the Hospital of Hyogo College of Medicine, also recently randomized their first patient in the trial.
“The Corvia IASD provides a much-needed therapeutic option for my heart failure patients. We are pleased to be a part of this landmark trial and we look forward to incorporating this technology into our heart failure treatment algorithm.”
– Professor Masanori Asakura, the Hospital of Hyogo College of Medicine
REDUCE LAP-HF II is a prospective, double-blind, sham-controlled clinical trial randomizing 608 HFpEF and HFmrEF patients in the US, EU, Australia, Japan, and Canada. The Corvia IASD received USA Food and Drug Administration (FDA) Breakthrough Device designation, underscoring its clinical significance and its potential to improve outcomes for heart failure patients, with the potential for accelerated USA market clearance.
“The Japanese investigators are pleased to participate in REDUCE LAP-HF II, a global trial of the InterAtrial Shunt Device (IASD) for patients with HFpEF and HFmrEF, for which effective treatment strategies have not been established. We hope this landmark trial will be a great success and provide important clinical evidence regarding the efficacy and safety of this novel therapy,”
– Professor Hiroyuki Tsutsui, Kyushu University and Primary Investigator for Japan
“We recognize the randomization of the first patients in Japan as an important advance in the clinical evaluation of the Corvia IASD. I would like to thank Professor Tsutsui and Professor Yamamoto, who provided clinical perspective and academic understanding to the protocol review by PMDA,” commented George Fazio, President, and CEO of Corvia Medical. “We would also like to thank the many physicians and research staff around the world for their continued support of the REDUCE LAP-HF II trial. Our technology has the potential to reduce recurrent heart failure hospitalizations and improve quality of life for many patients and we are encouraged by the trial’s momentum, bringing us one step closer to providing the Corvia IASD therapy to heart failure patients around the world.”
About Heart Failure
There are two types of heart failure: heart failure with reduced ejection fraction (HFrEF), also called systolic heart failure, and heart failure with preserved or mid‐range ejection fraction (HFpEF/HFmrEF), previously called diastolic heart failure. Ejection fraction (EF) is a measurement of how well blood is pumped out of the heart during a single contraction and is noted as a percentage, with normal range between 50%-75%, and mid-range between 40%-50%. HFpEF and HFmrEF occur when the muscles of the left ventricle become stiff and unable to relax normally. As a result, it cannot fill properly. This means the pressure inside the left heart chambers and the lungs increases. Medicines that are effective for treating the other type of heart failure (HFrEF) frequently do not work well for HFpEF or HFmrEF and treatment options are currently very limited.
About the Corvina InterAtrial Shunt Device (IASD®)
The Corvia InterAtrial Shunt Device is the world’s first transcatheter device to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the Corvia IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the Corvia IASD System aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients. The Corvia IASD System is an investigational device and not available for commercial distribution in the United States.
About Corvia Medical, Inc.
Corvia Medical, Inc. is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences and an undisclosed strategic investor.
1Hasenfuß G., Hayward C., Burkhoff D. et al. A Transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicenter, open-label, single-arm, phase 1 trial. Lancet 2016; 387;1298-304.
2Kaye D., Hasenfuß G., Neuzil P., et al. One-Year Outcomes After Transcatheter Insertion of an Intratrial Shunt Device for the Management of Heart Failure with Preserved Ejection Fraction. Circ Heart Fail. 2016.