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 Global Clinical 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.
Professor Koichiro Kinugawa, MD and his heart team randomized the first patient at the University of Toyama Hospital. Dr. Hiroshi Ueno commented, “We are very proud to be the first hospital in Japan to randomize patients in the REDUCE LAP-HF II Global Clinical Trial is a prospective, double-blind, sham-controlled clinical trial randomizing 608 HFpEF and HFmrEF patients in the US, EU, Australia, Japan and Canada. 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 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,” stated Professor Asakura. “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.”
REDUCE LAP-HF II Global Clinical Trial is a prospective, double-blind, sham-controlled clinical trial randomizing 608 HFpEF and HFmrEF patients in the US, EU, Australia, Japan and Canada. For more information visit https://ClinicalTrials.gov, NCT03088033. 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,” commented Professor Hiroyuki Tsutsui of Kyushu University and the 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.”