The clearance for commercialization in the European Union follows approval by the U.S. FDA in October 2016, and rounds out the top end of the Medtronic TAVI portfolio that includes 23 millimeter, 26 millimeter and 29 millimeter valves.
"We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI due to valve size," said Rhonda Robb, vice president and general manager of Medtronic's Heart Valve Therapies business.
Significantly, an XL version of the Evolut R surpasses the offering by the leader in the TAVI market, Irvine, Calif.-based Edwards Lifesciences, which tops out at with a 29 millimeter Sapien 3 valve.
Medtronic also may hold an edge over Edwards among physicians for the ability to reposition the valve during the implantation procedure.
"Consistent with the Evolut R platform, the 34 millimeter valve delivery system assists with accurate placement with the option to recapture and reposition if needed. This gives physicians great confidence that exceptional outcomes can be achieved for our patients" with large aortic root anatomies, said Darren Mylotte, interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland.
According to Robb the ability to treat patients with a larger native aortic annulus expands the eligible European TAVI patient population by 20 percent to 25 percent.
Significantly, the CE approval is for patients with an intermediate risk for undergoing traditional heart valve surgery, as well as for high and extreme risk patients. FDA approval does not include the intermediate risk patient group.
In a meeting with Medtronic management earlier in January 2017, Lawrence Biegelsen with Wells Fargo Securities LLC reported the company expected the Evolut R 34 would be available in Europe in February 2017 and that executives are confident it will drive strong growth.
According to Wells Fargo, Medtronic holds a 31.5 percent share of the European TAVI market, earning $332 million in sales revenue. That compares with a 52.3 percent market share for Edwards that is valued at $552 million in sales.
The leaders face increasing competition in Europe from new entrants such as St. Paul, Minn.-based St. Jude Medical (now part of Abbott Laboratories) with a 1.5 percent share, Natick, Mass.-based Boston Scientific Corp. capturing 7.4 percent of the European market and a cluster of other companies that have collectively claimed a further 7.3 percent market share.
In the U.S., where no valves are yet approved for new entrants, Edwards holds a 70 percent share of the TAVI market against 30 percent for the Medtronic Corevalve product line.
"It's important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients," said Mylotte.
The Evolut R 34 millimeter valve is delivered through the Enveo R Delivery Catheter System, which features an Inline Sheath, which Medtronic states is the lowest delivery profile currently on the market at 16 French. The clinical advantage is to treat patients with smaller vessels through the transfemoral access route.
In August 2016, Medtronic issued a warning to physicians to not force the passage of the Enveo R catheter as it could puncture or damage a blood vessel. The warning was prompted by 39 cases where patients' arteries were damaged during the procedure. Nineteen of those patients died.