Edwards Lifesciences Corp. has scored an approval from the U.S. FDA for the Konect Resilia aortic valved conduit, a ready-to-implant solution for bio-Bentall procedures.

The move represents an important step for those requiring such procedures, which are complex and involve the replacement of a patient’s aortic valve, aortic root and the ascending aorta. These procedures are performed when patients with valve disease experience a combination of issues with the aorta, including aneurysm, regurgitation, separation or tears in the walls of the aorta and Marfan’s syndrome, a birth defect in connective tissue that weakens the aortic wall.

Cowen’s Josh Jennings estimated the annual opportunity with the device to be in the $50 million to $100 million-plus range for the surgical structural heart unit. “Konect Resilia has the potential to deliver hundreds of bps plus to the annual organic revenue growth trajectory of the SAVR [surgical aortic valve replacement] unit, which will help to offset TAVR [transcatheter aortic valve replacement] cannibalization of SAVR volumes with deeper penetration in low risk patients.”

Jennings also saw promise on this front moving forward. "[Edwards] continues to invest in the development of innovative products for the Surgical Structural Heart unit, and we expect Konect Resilia will help [Edwards] extend its leadership in the ~$2B global surgical structural heart annual opportunity,” he wrote.

Filling an unmet need

“This is a complex patient group that is small, yet there is a great unmet need,” Daveen Chopra, Irvine, Calif.-based Edwards’ corporate vice president, surgical structural heart, told BioWorld when asked about the number of individuals that could be treated annually with the option. He went on to note that the company previously had pegged the number of patients with this need and treated surgically in the U.S. or Europe each year at roughly 11,000. “We’re very excited to launch this product and about the opportunity to help more patients.”

Looking at the device broadly, it uses Resilia tissue, which incorporates integrity-preservation technology that may help improve valve durability. For his part, Joseph Bavaria, the Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania, expressed enthusiasm about now having a pre-assembled, FDA-approved option for this patient population. He said that he expects it will streamline treatment for those needing this complex, technical procedure.

“Historically, if surgeons were to use a bovine tissue valve, they would have to manually assemble the valve with a conduit during the surgery to not only replace that valve, but they also have to do work on the root of the ascending aorta,” Chopra continued. “Konect streamlines and saves time in complex procedures for surgeons as the product is pre-assembled. Resilia also features preservation technology for dry storage, further facilitating ease of use for the surgeon.”

In addition, with the small patient population, the company’s focus is on providing a solution for these individuals rather than lowering health care costs. “Because the patient group is small, there is limited opportunity for a large-scale impact on health care costs. However, Edwards wants to continue to be the partner of choice for the cardiac surgeon and we are continuing to invest in and develop a leading pipeline of patient-oriented surgical innovations,” Chopra confirmed.

He further noted that Bentall procedures typically are done in emergency situations in a relatively young population. “The Konect device with the Resilia tissue … may help provide extended valve durability for an active patient population, typically under the age of 60,” he added.

In terms of rollout plans, Chopra noted that these procedures are complex and typically done at larger facilities. "Initially, Konect will be commercially available in these U.S. hospitals, starting this quarter.” He added that the company is focused on the U.S. currently, but approvals in other geographies would come "gradually over time.”

No Comments