CE mark approval for Intuity Elite valve system


Edwards Lifesciences announced it has received CE mark approval for the advanced Edwards Intuity Elite valve system. This next-generation rapid deployment system facilitates smaller incisions in surgical aortic valve implantation (AVI) procedures, and is built upon extensive evidence supporting the durability of the Carpentier-Edwards Perimount heart valve design.

“Smaller incisions, reduced cross-clamp time and improved haemodynamics are advances that have the potential to improve outcomes in many patients who undergo surgical aortic valve replacements in the UK each year,” says Chris Young, consultant surgeon at St Thomas’ Hospital, London, UK. “Edwards Intuity Elite represents the next step in offering patients a less-invasive and more efficient surgical approach, and is designed to greatly enhance the results of surgery.”

According to Edwards Lifesciences, the next-generation Edwards Intuity Elite valve system combines a unique balloon-expandable frame with Edwards’ proven pericardial Perimount platform, which has demonstrated durability up to 25 years in published studies. The new system has design improvements intended to improve ease of use, including a flexible and lower profile delivery system that is designed to facilitate access and visibility through smaller incisions.

Data from 100 patients in the CADENCE-MIS trial, a randomised, controlled, multicentre trial comparing minimally-invasive AVI with the Edwards Intuity valve system to full sternotomy AVI with any conventional bioprosthetic aortic valve, were recently presented at the 2014 Annual Meeting of the Society of Thoracic Surgeons (STS). The trial found:

– Minimally-invasive AVI with the Edwards Lifesciences platform demonstrated a statistically significant reduction (24%) in ischaemic time (the amount of time blood flow to and from the heart is stopped during surgery) compared to the full sternotomy approach with conventional bioprosthetic valves.  These results are especially meaningful as minimally-invasive approaches have traditionally been associated with longer ischaemic times; and

– Improved blood flow and haemodynamics with the Edwards Intuity valve compared to conventional bioprosthetic valves at three-month follow-up.

Additionally, an interim analysis of 158 patients undergoing isolated aortic valve replacement in the prospective, multicentre, single-arm TRITON Trial for the Edwards Intuity platform, found that 55% were performed through a minimally invasive approach, as opposed to a full sternotomy.

The Edwards Intuity Elite valve system is currently being studied as part of the TRANSFORM trial, the first US clinical trial of a rapid deployment system for surgical aortic valve implantation. It is an investigational device and not yet available for sale or use in the United States. The system will be commercially available at hospitals throughout Europe and is supported with favourable reimbursement in Germany as part of diagnosis-related group (DRG) mapping that includes the new category of rapid-deployment aortic valve systems.