Edwards Lifesciences obtains CE Mark for its EDWARDS INTUITY Elite Valve System

7 April 2014 (Last Updated April 7th, 2014 01:00)

US-based Edwards Lifesciences has received CE Mark approval for its next-generation EDWARDS INTUITY Elite valve system.

US-based Edwards Lifesciences has received CE Mark approval for its next-generation EDWARDS INTUITY Elite valve system.

This advanced valve system is built on extensive evidence supporting the durability of the Carpentier-Edwards PERIMOUNT heart valve design, adding a new feature to facilitate rapid deployment and provide enhanced visibility through smaller incisions.

Leipzig Heart Center in Germany associate director of the department of cardiac surgery Dr Michael Borger said the centre is encouraged by the introduction of heart valve technologies that is developed to facilitate a minimally invasive approach for the improved treatment of patients with aortic valve disease.

"Our experience with the EDWARDS INTUITY platform has shown the ability to implant the valve through smaller incisions, with significantly reduced cross-clamp time and improved hemodynamics," Dr Borger said.

"This less-invasive, more efficient surgical approach should benefit patients during and after their procedure."

"This less-invasive, more efficient surgical approach should benefit patients during and after their procedure."

According to the company, the next-generation EDWARDS INTUITY Elite valve system, a combination of balloon-expandable frame and Edwards' pericardial PERIMOUNT platform, demonstrates durability of up to 25 years in published studies.

In addition, 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 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.

The clinical data from 100 patients from CADENCE-MIS trial were presented earlier at the 2014 Annual Meeting of the Society of Thoracic Surgeons, which showed improved blood flow and haemodynamics with the EDWARDS INTUITY valve compared to conventional bioprosthetic valves at three-month follow-up; with minimally invasive AVR with the EDWARDS INTUITY platform demonstrating a statistically significant reduction in ischemic time, compared with the full sternotomy approach with conventional bioprosthetic valves.

Edward's corporate vice-president, heart valve therapy Donald Bobo Jr said the company has enhanced the EDWARDS INTUITY design to further meet the needs of patients, physicians and hospitals with a valve and procedure that can be readily incorporated into the surgeon's treatment offerings.

"We believe the EDWARDS INTUITY platform can greatly expand the population of patients who receive the less-invasive approach with important clinical and cost benefits," Bobo said.

The EDWARDS INTUITY Elite valve system is currently being studied as a part of the TRANSFORM Trial, the first US clinical trial of a rapid deployment system for surgical aortic valve replacement.

Currently, the EDWARDS INTUITY Elite valve system is an investigational device and not yet available for sale or use in the US. The company plans to make the device available immediately to hospitals throughout Europe.

The new device 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.