Medtronic’s New Transapical Valve: Study Points To Paravalvular Leak Reduction

In short

It’s EACTS week and Medtronic, Inc. is trumpeting clinical results relating to its own Transcatheter Valve system, which have been presented at the event. First results from the multi-centre trial support the safety and clinical performance of the company’s second generation valve, which uses a transapical delivery approach to treat patients with severe aortic stenosis who were at high or extreme risk for surgical aortic valve replacement (SAVR).

Background

The Engager transapical valve is designed for minimally‐invasive delivery via a catheter inserted in the apex of the heart. The valve is Medtronic’s second transcatheter offering and like CoreValve is comprised of bovine tissue leaflets and a self‐expanding nitinol frame designed to aid in valve positioning. The valve’s claim to fame is its design which is intended to promote annular sealing and thereby minimise paravalvular leak, one of the biggest challenges for a transcatheter valve.

The positive clinical outcomes, presented during a late-breaking trials session at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting, revealed that the Engager system was deployed in the anatomically correct position in all 60 patients. The Engager valve demonstrated strong hemodynamic performance with low transvalvular gradients, and no patients experienced greater than trace paravalvular leak at 30 days as measured by an independent echocardiography core lab. There were no procedures requiring a second valve, and no occurrences of valve embolisation, coronary obstruction or device malposition. The 30-day all-cause mortality rate was 9.9 percent, the cardiovascular mortality rate was 8.3 percent, and the incidence of stroke was 1.8 percent.

Physician comments

“Results from the European Pivotal Study indicate that the Engager valve’s design facilitates precise positioning and reduces paravalvular regurgitation, improving two of the most important clinical challenges faced in transcatheter aortic valve implantation. The Engager valve is a valuable new technology and will allow heart teams to meet the varying needs of patients with severe aortic stenosis,” said Hendrik Treede, M.D., Engager Pivotal Trial investigator, University Heart Center Hamburg in Hamburg, Germany.

Company comments

“We are very pleased with these 30-day results from the Engager system,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “The Engager system is a key component of Medtronic’s approach to bring heart teams a portfolio of transcatheter valve solutions that consistently delivers optimum fit, deliverability and performance to meet the diverse needs of their patients.”

Regulatory status

The Engager valve is not available for use outside this Pivotal Trial and is currently being reviewed for its CE Mark.

Source: Medtronic, Inc.