An announcement was made today by the Corvia Medical, Inc. about the randomization of patients in Toyama and Hyogo in the REDUCE LAP-HF II trial, a clinical trial authorized by the Pharmaceutical and Medical Device Agency (PMDA). The Covia Medical provides first-class treatment for heart failures through its transcatheter device, the first of its kind in the world, the Corvia InterAtrial Shunt Device (IASD®).
The first patients of the team lead by Professor Koichiro Kinugawa were randomized at the University of Toyama Hospital. Dr. Hiroshi Ueno said that it is an immense pleasure for them to be the first Japanese hospital randomizing patients for the trial. He further said that the treatment options are currently limited for the heart failure patients and the previous positive results shown by the Corvia IASD are encouraging for him.
Patients were randomized in the first trial by the Hospital of Hyogo College of Medicine Professor, Masanori Asakura, as well. Professor Asakura said that his patients who suffered from heart failure were provided with therapeutic options by the Corvia IASD which was much needed. The Professor seemed quite pleased being a part of this trial and promised his output in this technology.
Six hundred and eight patients with HFpEF and HFmrEF to be randomized by the sham-controlled, double-blind trial, REDUCE LAP-HF II, from across the United States, Canada, Australia, EU, and Japan. FDA, the Food and Drug Administration of the US, provided the Corvia IASD with the designation of Breakthrough Device which highlights the clinical importance of the Corvia IASD.
The Japanese Chief investigator and Kyushu University Professor, Hiroyuki Tsutsui, said that it is a pleasure for the Japanese investigators participating in the global trial of InterAtrial Shunt Device (IASD), REDUCE LAP-HF II, which works for patients suffering from HFpEF and HFmrEF, with unestablished effective strategies for their treatment. He further hoped for the success of this trial and key clinical proofs regarding the therapy’s safety and efficacy to be provided.