US-based medical devices company Abbott has obtained CE Mark approval for the new FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system.

The new FlexNav delivery system is said to provide physicians implanting Portico Valve with improved delivery, flexibility and navigation, even in complex cardiac anatomies.

Abbott structural heart business chief medical officer Neil Moat said: “Within the field of TAVI, delivery systems often don’t receive the attention of the evolving technology of the valves themselves, but improvements to a delivery system can result in substantial benefits to patients.

“If we look at the total TAVI procedure, innovation around both the valve itself and also how it’s delivered during an implant are both central to improving outcomes.”

Portico TAVI and FlexNav delivery system approved only for investigational use in US

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure, performed as an alternative to surgical aortic valve replacement for patients diagnosed with severe aortic stenosis, a condition which restricts blood flow through the valve, and who are at high risk for open heart surgery.

The advancements in valve technology have contributed for reduction in adverse events and improving patient outcomes, the delivery systems used for placement and positioning of the valve are required to be improved, said the company.

Abbott has developed the new FlexNav delivery system, based on physician feedback, to incorporate more stability, predictability and placement accuracy into the TAVI procedure.

In addition, Portico valve implanted using the new delivery system has demonstrated positive outcomes for patients, including no deaths, no strokes and reduced rates of major vascular complications, in the investigational device exemption (IDE) study.

In the US, the Portico transcatheter aortic valve and FlexNav delivery system are approved for investigational use only.

FlexNav IDE trial principal investigator Francesco Bedogni said: “As a therapy, TAVR is now fairly mainstream and has helped countless patients around the world live better lives, but physicians have continued to seek improvements to how we deliver a valve to optimize outcomes for our patients.

“With Abbott’s new FlexNav delivery system, the company has introduced a delivery system that improves the implant process even in incredibly complex cardiac anatomies.”