CAUTION–Investigational Device. Limited by United States Law to Investigational Use.
MUNICH, GERMANY – August 27, 2018 — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced one-year follow-up data from the REDUCE LAP-HF I clinical study of its Interatrial Shunt Device (IASD®). The IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. Data was presented in the late-breaking scientific session at the European Society of Cardiology meeting. Dr. Ted Feldman from Evanston Hospital in Illinois presented the results on behalf of the investigators and research staff.
REDUCE LAP- HF I is a prospective, double-blind, mechanistic study of 44 patients randomized to IASD or sham control. Primary study endpoints at 30 days included effectiveness of the IASD as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction compared to sham control, and procedural safety as assessed by major adverse cardiovascular, cerebral, or renal events (MACCRE). The study met its primary endpoint.
The one-year results demonstrate shunt patency (blood flow from the left to right atrium) for all participants who received the implant. Results further showed the IASD is safe, improved quality of life and is associated with favorable trends in heart failure hospitalization and reduction in New York Heart Association (NYHA) heart class. Results are published today in JAMA Cardiology.
“The REDUCE LAP-HF I clinical study is of tremendous interest to me because HFpEF is a clinical problem for which there is no effective therapy,” commented Ted Feldman, M.D., Evanston Hospital in Illinois and co-principal investigator. “We’ve now studied the IASD in several consecutive trials. The early single-arm studies demonstrated that people felt better and their exercise capacity improved. Now, a sham-controlled randomized study conclusively proves the mechanism of action and again suggests clinical efficacy in midterm follow-up.”
Sanjiv Shah, M.D., Northwestern Memorial Hospital’s Center for Heart Failure at the Bluhm Cardiovascular Institute in Chicago, and co-principal investigator, commented “I am pleased with the results of the REDUCE LAP-HF trials so far. By leading and taking part in these studies, we hope to make a significant difference for patients who suffer from the devastating effects of this type of heart failure.”
“The data presented today by Dr. Feldman once again demonstrate the potential benefit of IASD therapy for the large underserved heart failure population,” said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. “While this particular study was focused on demonstrating a mechanistic effect and by design, underpowered for other outcome measures, the clinical results are consistent with prior trials confirming the IASD provided symptom relief, improved quality of life, and reduced heart failure events. We now are focused on demonstrating, in the ongoing REDUCE LAP-HF II study, that these positive clinical outcomes are robust enough, in a larger patient population, to carry this new technology into clinical practice.”
REDUCE LAP-HF II is a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients. Recruitment is ongoing.
About the InterAtrial Shunt Device (IASD®)
The Interatrial Shunt Device is the world’s first transcatheter device approved in the European Union to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (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 physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD 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. For more information, please 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 Ventures and an undisclosed strategic investor. For more information, please visit http://corviamedical.com/.