Second-generation transapical valves: the Medtronic Engager system.

Area of Science:

• Cardiovascular Surgery
• Medical Devices
• Bioprosthetics

Background:

• Transcatheter aortic valve implantation (TAVI) offers a less invasive alternative for aortic valve replacement.
• Second-generation TAVI systems aim to improve device stability and reduce complications like paravalvular leakage.

Purpose of the Study:

• To describe the technical aspects of the Medtronic Engager aortic valve system.
• To detail the implantation technique for transapical delivery of the bioprosthesis.
• To highlight key procedural steps for optimal device placement and function.

Main Methods:

• The Medtronic Engager system features a self-expandable stent with control arms for precise positioning within the aortic sinuses.
• A bovine pericardium tri-leaflet valve is integrated onto the stent.
• The delivery system is designed for over-the-wire transapical implantation, utilizing rotational positioning of commissural posts.

Main Results:

• A multicenter feasibility study indicated promising initial outcomes.
• A subsequent European pivotal trial provided results that supported CE mark approval in 2013.
• The device's design, including a lower skirt, aims to minimize paravalvular leakage.

Conclusions:

• The Medtronic Engager aortic valve system represents an advancement in TAVI technology.
• The described implantation technique facilitates accurate and stable valve placement.
• CE mark approval signifies the system's clinical acceptance and potential for widespread use.