CAUTION–Investigational Device. Limited by Federal (or United States) Law to Investigational Use.
Corvia Medical Announces Enrollment of First Patients in Pivotal Trial of the IASD® System II for the Treatment of Heart Failure
Data from randomized feasibility trial to be presented at the American Heart Association Scientific Sessions 2017
ANAHEIM, CA – November 14, 2017 — Corvia Medical, Inc., a privately-held medical device company that developed a first-in-class transcatheter structural heart device to treat heart failure, today announced that it has enrolled the first patients in its global multicenter trial (REDUCE LAP-HF II) of the Interatrial Shunt Device (IASD) for the treatment of heart failure. Results from the randomized feasibility trial (REDUCE LAP-HF I) will be presented at the American Heart Association meeting on Wednesday, November 15th in Anaheim, CA.
Dr. Sanjiv Shah from Northwestern Memorial Hospital’s Center for Heart Failure at the Bluhm Cardiovascular Institute in Chicago will be presenting on behalf of the investigators, at the Innovative Therapies and Novel Applications session of the Late-Breaking Science program. The presentation, titled Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Results from the REDUCE LAP-HF I randomized controlled trial, will be presented at 9:00am PT on Wednesday, November 15th.
Dr. Rami Kahwash, heart failure cardiologist at the Ohio State University Wexner Medical Center enrolled the first patient in the REDUCE LAP-HF II trial, the next study to evaluate the IASD in support of US FDA approval. He commented, “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.” Dr. Kahwash continues, “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.”
The REDUCE LAP-HF II trial is a prospective, multicenter, double blind randomized controlled trial to evaluate the IASD System to reduce elevated left atrial pressure in patients with heart failure with preserved or mid-range ejection fraction. The study will enroll patients at up to 70 sites in the U.S. and up to 30 sites outside the U.S. Dr. Sanjiv Shah and Dr. Ted Feldman from the NorthShore University HealthSystem in Evanston, Illinois, serve as co-principal investigators for the study.
“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,” commented Dr. Ted Feldman, “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.”
“Enrolling the first patients in the pivotal trial is a major step toward bringing this innovative technology to patients in the United States,” said George Fazio, President and CEO of Corvia Medical. “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.”
About the InterAtrial Shunt Device (IASD®)
The IASD is the world’s first transcatheter device approved in the European Union to treat heart failure with preserved or mid-range ejection fraction (HFpEF/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 during physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD is designed to reduce heart failure symptoms. Ameliorating the symptoms of heart failure can lead to improved quality of life, decreased heart failure hospitalization rates, and a reduction in the overall cost burden of managing heart failure patients. For more information, 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 Capital and an undisclosed strategic investor. For more information, please visit https://corviamedical.com/.
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