Update: Corrected from previously mislabeled ‘interarterial’ to ‘interatrial’ shunts
Corvia Medical said today it launched the Reduce LAP-HF II clinical trial of its transcatheter Interatrial Shunt Device designed to treat heart failure as it seeks FDA approval of the device.
The Tewksbury, Mass.-based company said the 1st patient in the trial was enrolled by Dr. Rami Kahwash of the Ohio State University Wexner Medical Center.
“The treatment of heart failure with preserved ejection fraction is challenging, and caring for these patients can be frustrating. Multiple randomized drug trials have demonstrated that conventional heart failure medications are ineffective in this type of heart failure and as a result, patients have limited therapeutic options. Since heart failure symptoms are directly linked to elevated left atrial pressures, the interatrial shunt device has the potential to offer an effective treatment by facilitating continuous and dynamic decompression of the left atrium, subsequently reducing symptoms and improving quality of life for this patient population,” Dr. Kahwash said in a press release.
Corvia Medical’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 Reduce LAP-HF II trial is a prospective, double-blind and randomized controlled trial looking to enroll patients at up to 70 sites in the US and 30 outside the US. The trial aims to evaluate the IASD System’s ability to reduce elevated left atrial pressure in patients with heart failure and preserved or mid-range ejection fraction, the company said.
“Having experience with the IASD in prior studies, I have substantial appreciation for the elegance of the implant procedure and have been very satisfied with the positive effect it has had. The open label study showed that following IASD implantation, patients had significantly fewer heart failure symptoms and could exercise significantly longer, giving them a substantially better quality of life. We are pleased to be part of the pivotal study and continue to offer this innovative treatment to our heart failure patients,” co-principal investigator Dr. Ted Feldman of Evanston, Ill.’s NorthShore University Health System said in a prepared statement.
“Enrolling the first patients in the pivotal trial is a major step toward bringing this innovative technology to patients in the United States. This large randomized trial demonstrates our commitment to building a body of strong clinical evidence to meet a significant unmet clinical need by advancing care for patients suffering with the debilitating symptoms of heart failure,” prez & CEO George Fazio said in prepared remarks.
Last November, Corvia Medical released 1-year results from the Reduce LAP-HF clinical trial of its IASD, touting a good safety profile and sustained device performance.