GERMANY – Medtronic, a global leader in medical technology, has introduced its latest innovation, the Avalus Ultra bioprosthetic valve, to Western Europe.
The first successful implantations of this new valve took place at the renowned Heart Center in Leipzig, Germany, under the leadership of Dr. Michael Borger.
The two aortic valve replacements were completed using minimally invasive techniques, showcasing the versatility and advanced design of the Avalus Ultra.
The formal European launch of the Avalus Ultra was announced during the European Association for Cardio-Thoracic Surgery (EACTS) annual congress in Lisbon.
Medtronic highlighted the significant improvements Avalus Ultra offers over its predecessor, focusing on ease of implantation and enhanced patient management for aortic valve disease.
As part of the congress, investigators will also present seven-year outcomes from the Avalus valve at the event, demonstrating the long-term durability and performance of the valve in real-world settings.
Medtronic’s PERIGON pivotal study, which involved 1,123 patients across 39 centers in eight countries, serves as the largest prospective study of any contemporary stented surgical valve.
Key features of the Avalus Ultra Valve
The Avalus Ultra bioprosthetic valve is designed to enhance both surgical procedures and patient outcomes.
Its key features include straightforward sizing and clear visibility, simplifying valve-in-valve procedures for future interventions.
The valve’s polyetheretherketone (PEEK) base frame ensures consistent circularity, contributing to its low profile and precise placement.
Additionally, the valve offers an industry-leading effective orifice area (EOA), promoting better blood flow for patients with aortic stenosis.
A radiopaque coil further enhances visibility during imaging, making it easier for surgeons to perform future procedures.
Building on the original Avalus valve launched in 2017, the Avalus Ultra benefits from over a decade of clinical experience, reinforcing its reliability for surgical aortic valve replacement (SAVR).
Expanding access to life-saving cardiac treatments
Karim Bandali, President of Medtronic’s Cardiac Surgery division, expressed enthusiasm about the European launch, stating, “We are thrilled to expand access to the Avalus Ultra valve, especially at such a prestigious event like the EACTS congress.
This launch, along with our other innovations like the Penditure LAA exclusion system and VitalFlow ECMO system, further solidifies Medtronic as a leader in cardiac surgery technologies.”
The Avalus Ultra valve is an integral part of Medtronic’s comprehensive strategy to address complex cardiovascular diseases.
Additional innovations
Medtronic’s Avalus Ultra launch follows the introduction of other groundbreaking devices, including the Penditure left atrial appendage (LAA) exclusion system and the VitalFlow extracorporeal membrane oxygenation (ECMO) system.
Penditure, a single-use device designed for LAA management during cardiac surgery, was developed to match atrial anatomy and reduce inflammation without the need for fabric.
It was acquired from Syntheon in August and quickly received FDA clearance, now available in the U.S. on a limited basis.
Penditure stands out as the only LAA clip on the market that can be recaptured, repositioned, and redeployed during a procedure, providing surgeons with more control and flexibility, according to the medtech giant.
Noteworthy Medtronic’s competitors in this space include Abbott’s Amplatzer Amulet, Boston Scientific’s Watchman, and AtriCure’s AtriClip.
