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March 23, 2020

First Patient Treated With CroíValve’s Duo Tricuspid Coaptation Valve Technology

March 23, 2020—CroíValve announced the successful first human use of its Duo tricuspid coaptation valve technology for tricuspid repair. CroíValve was spun out of Trinity College Dublin in early 2019 and is headquartered in Dublin, Ireland.

The procedure, which was approved by the Irish regulatory body under their compassionate use program, was performed at St. James University Hospital Dublin by a heart team led by interventional cardiologist Stephen O’Connor, MD, and cardiac surgeon Michael Tolan, MD.

According to the company, the Duo tricuspid coaptation valve technology provides a simple and atraumatic approach for addressing severe tricuspid regurgitation (TR) in high-risk patients.

CroíValve reported that the patient had severe TR with reduced heart function and was at risk of further deterioration in heart function with treatment of the tricuspid valve. Based on this, the patient had been turned down for open surgical repair.

Because the atraumatic approach of the Duo device allows for temporary implantation of the device to restore function without any impact to the native anatomy, the St. James heart team elected to assess the acute effect of tricuspid valve repair on heart function.

The procedure, delivery, and retrieval were completed fully percutaneously, with the device delivered in 5 minutes without complications.

TR was reduced from torrential to mild and the mean right atrial pressure reduced from 26 to 13 mm Hg, with an increase in systolic blood pressure, while the device was in situ. No significant change in right ventricular function was noted during the 30 minutes that the device was in place. The patient is recovering well from the intervention, and permanent transcatheter repair of her valve is planned due to the positive cardiac response to treatment.

In the company’s press release, Dr. O’Connor commented, “Early use of the CroíValve system indicates it to be an easy-to-use, safe, and effective intervention for patients with severe TR.”

Dr. Tolan added, “The unique capability of the Duo coaptation valve to restore tricuspid valve function atraumatically while facilitating straightforward percutaneous removal enabled us to determine a strategy to treat the patient. Considering this patient has had significant suffering from this disease and had no other options, we are extremely proud the physicians and staff at St. James University Hospital found an innovative approach to understanding the right treatment approach for this patient.”

The device is currently being evaluated in a clinical study in Poland to assess the impact of correction of severe TR in patients before surgical intervention. The system is also in development for permanent implantation, with clinical studies planned for early next year, advised CroíValve.

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