Corvia Medical said today that a clinical trial of its Interatrial Shunt Device for treating heart failure met its primary endpoints at one year.
Tewksbury, Mass.-based Corvia last November launched the Reduce LAP-HF II clinical trial ahead of a bid for FDA approval. The company’s IASD is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s indicated for diastolic heart failure, also known as heart failure with preserved ejection fraction.
The 44-patient study is a prospective, double-blind and randomized controlled trial comparing treatment with the IASD and a sham procedure, with primary endpoints of exercise pulmonary capillary wedge pressure reduction and major adverse cardiovascular, cerebral or renal events, both at 30 days.
One year results from the study, presented today at the European Society of Cardiology annual meeting in Munich by co-principal investigator Dr. Ted Feldman and published in JAMA Cardiology, showed patency in the shunts of all IASD-treated patients and no significant difference in the safety endpoint for both the control and treatment arms.
The trial “confirms the longer-term patency of the IASD. Through 1 year of follow-up, IASD treatment appears safe, with no significant differences in MACCRE in patients receiving IASD compared with those who received sham control treatment,” the study authors wrote.
“The data presented today by Dr. Feldman once again demonstrate the potential benefit of IASD therapy for the large underserved heart failure population,” SVP and chief medical officer Jan Komtebedde said in prepared remarks. “Although 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.”
“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,” added Feldman, of Evanston Hospital in Illinois.
In November 2016, Corvia released 1-year results from the Reduce LAP-HF clinical trial of its IASD, touting a good safety profile and sustained device performance.