Corvia Medical launches Interarterial Shunt Device heart failure trial

Corvia Medical said today it launched the Reduce LAP-HF II clinical trial of its transcatheter Interarterial 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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Regulatory/Compliance Corvia Medical Source Type: news