First Implants in US Study of the Portico Transcatheter Aortic Heart Valve System
St. Paul, MN - St. Jude Medical, a global medical device company, today announced that the first patient implants occurred in the Portico™ Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO trial). The trial is evaluating the Portico™ Transcatheter Aortic Valve System, the first aortic heart valve that is repositionable until fully deployed. The trial will enroll patients who are considered to have a high or an extreme surgical risk (meaning they would not be considered) for open-heart surgery.
The PORTICO trial is evaluating the Portico valve and delivery system in patients with symptomatic severe aortic stenosis – a narrowing of the aortic valve that significantly impedes blood from flowing out of the heart. During transcatheter aortic valve replacement (TAVR) procedures, a Portico heart valve is delivered via a catheter using either a transfemoral (through the artery in the leg) or an alternative access approach in order to gain access to the heart. The Portico valve is positioned in the patient’s heart as it continues to beat, alleviating the need for cardiopulmonary bypass, where a machine takes over a patient’s heart and lung function. Patients are evaluated by a heart team consisting of a cardiac surgeon and an interventional cardiologist. Continue>
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