TEWKSBURY, Mass., Dec. 21, 2017 /PRNewswire/ -- Corvia Medical, Inc., a privately-held medical device company that developed a first-in-class transcatheter structural heart device to treat heart failure, presented primary endpoint results from the REDUCE LAP-HF I randomized study of its Interatrial Shunt Device (IASD®) at the 2017 American Heart Association (AHA) Scientific Sessions in Anaheim, CA. The IASD is the world's first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure.
Dr. Sanjiv Shah from Northwestern Memorial Hospital's Center for Heart Failure at the Bluhm Cardiovascular Institute in Chicago presented the data on behalf of the investigators and research staff.
REDUCE LAP- HF I is a prospective, double-blind, randomized study of 44 patients in two arms: IASD arm or sham control arm. Study endpoints included the effectiveness of the IASD as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction compared to sham control, and safety of the procedure as assessed by major adverse cardiovascular, cerebral, or renal events (MACCRE). Results demonstrated the mechanistic effect of the IASD. Study highlights include:
- Met the primary endpoint of significantly reduced exercise PCWP at variable stages of exercise at one month for the IASD arm compared to the control arm (P=0.028)
- Favorable single stage hemodynamic effects in the IASD arm were most apparent with legs up (P=0.024) and during exercise at 20W (P=0.019)
- Resting right ventricular cardiac output significantly increased compared with the control arm (P<0.001), indicating shunt flow
- The IASD showed a strong safety profile with no MACCRE event.
"There are no proven therapies to improve outcomes of HFpEF patients despite an increasing prevalence and high morbidity and mortality of these patients," said Dr. Shah. "The IASD is a new approach to the treatment of this chronic condition and the study results demonstrate the device is doing what it is supposed to do mechanistically by lowering left atrial pressure during exercise. We have recently started enrolling patients in a large pivotal trial for the IASD, looking at patient symptoms, quality of life, and important hard clinical outcome metrics such as heart failure hospitalization."
"The results of the REDUCE LAP-HF I study are very consistent with two earlier IASD studies showing PCWP reduction in this patient population," said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. "The IASD device met the very important mechanistic endpoint in this study while maintaining its excellent safety profile, and set the effectiveness standard for trials of similar devices using exercise hemodynamics. We look forward to completing enrollment in our large international pivotal trial, REDUCE LAP-HF II to demonstrate the clinical benefit of the IASD in this large and underserved heart failure population."
The REDUCE LAP-HF II trial is a prospective, multicenter, double-blind randomized controlled trial to evaluate the IASD System to reduce elevated left atrial pressure in patients with heart failure with preserved or mid-range ejection fraction. This study will evaluate the clinical efficacy of the IASD to support of U.S. FDA approval and will enroll patients at up to 70 sites in the U.S. and up to 30 sites outside the U.S. Dr. Sanjiv Shah and Dr. Ted Feldman from the NorthShore University HealthSystem in Evanston, Illinois, serve as co-principal investigators for the study.
About the Interatrial Shunt Device (IASD®)
The IASD is the world's first transcatheter device approved in the European Union to treat heart failure with preserved or mid-range ejection fraction (HFpEF/HFmrEF). After creating a small opening in the atrial septum, the 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 IASD is designed to reduce heart failure symptoms. Ameliorating the symptoms of heart failure can lead to improved quality of life, decreased heart failure hospitalization rates, and a reduction in the overall cost burden of managing heart failure patients. For more information, visit http://treatmyheartfailure.com/. The IASD 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 Capital and an undisclosed strategic investor. For more information, please visit http://corviamedical.com/.
SOURCE Corvia Medical, Inc.