European Study Sees First Implant For New Size St.Jude Portico™ Heart Valve

In short

St. Jude Medical, Inc. has announced the first patient implant of its 25 mm Portico™ Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial.

Background

The Portico valve system offers a minimally invasive treatment option for patients with severe aortic stenosis. These patients are often too sick and have co-morbidities that prevent them from having conventional open-heart valve replacement surgery.

St.Jude’s Portico Transfemoral European Trial (Portico TF EU Trial) was established to evaluate the 23 mm Portico valve, which recently received European approval. The study has now been expanded to include the 25 mm iteration. The trial will enroll up to 50 patients across Europe and data from the study will be used to support CE Mark approval.

One of the biggest concerns of interventional cardilogists when inserting TAVI devices is that of paravalvular regurgitation, where the valve is not perfectly seated in the desired location and suffers a degree of leakage around its periphery, with associated co-morbidities. St.Jude reckon their Portico valve is capable of being seated correctly more often than competitive offerings because of the ability to re-sheath it until completely satisfied. It no doubt hopes that combining this with valves sized appropriately for their target location ought to mean paravalvular leakage is minimised. Expanding the Portico TF EU trial to include the 25 mm Portico valve size therefore allows physicians to increase their research of the technology in patients whose anatomy requires this larger valve size.

Company comments

“The start of the Portico TF EU Trial for the 25 mm Portico valve is another major milestone in our transcatheter valve program and an indication of our commitment to provide new options to patients suffering from aortic valvular heart disease,” said Frank J. Callaghan, president of the Cardiovascular and Ablation Technologies Division at St. Jude Medical.

Regulatory status

The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System are not yet approved for use in the United States. A U.S. clinical trial evaluating the Portico valve is expected to start later this year. The trial will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE).

Source: St.Jude Medical, Inc., Business Wire