Privately-held Corvia Medical said its investigational transcatheter structural heart device to treat heart failure has demonstrated success in reducing exercise pulmonary capillary wedge pressure in trial patients.
This morning, the company said its device, called the Interatrial Shunt Device (IASD) significantly reduced PCWP at one month compared to control. Data was presented at the 2017 American Heart Association (AHA) Scientific Sessions in Anaheim, Calif. Corvia said the IASD is the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure.
The IASD implant is placed in the atrial septum to form a passage between the chambers. The IASD allows the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure. Through continuous decompression the IASD is designed to reduce heart failure symptoms, which leads to quality of life improvements.
The trial was conducted to demonstrate the device’s efficacy in reducing elevated left atrial pressure in patients with heart failure with preserved or mid-range ejection fraction. Trial results show that favorable single stage hemodynamic effects in the IASD arm were most apparent with legs up (P=0.024) and during exercise at 20W. Additionally, the company said resting right ventricular cardiac output significantly increased in comparison with the control arm, which indicates shunt flow.
In addition to meeting positive endpoints, Corvia said there were also no safety issues during the trial.
Dr. Sanjiv Shah from Northwestern Memorial Hospital’s Center for Heart Failure in Chicago presented the data. He said there are no proven therapies to improve outcomes of HFpEF patients “despite an increasing prevalence and high morbidity and mortality of these patients.” Corvia’s IASD is a new approach to treatment of the condition and the study is proof of its efficacy, he said.
“…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,” Shah said in a statement.
Corvia Chief Medical Officer Jan Komtebedde noted that the results of the REDUCE LAP-HF I study are consistent with previous studied showing PCWP reduction in this patient population.
“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,” Komtebedde said in a statement.
In 2016 the IASD earned CE Mark approval in Europe.
