NEW YORK A novel device by Medtronic Inc (MDT.N) to relieve high blood pressure faces an uphill battle in Europe, where cash-strapped government health plans are reluctant to pay for an innovation they do not understand well, the company's chief executive said.
Launched in April 2010, the therapy, called renal denervation, has proved effective in reducing high blood pressure by deadening nerves in the kidneys. It is intended for patients who do not respond to traditional hypertension medications.
Reimbursement for the product, however, has been hard to come by, which has limited its adoption in Europe, Medtronic CEO Omar Ishrak said at the Reuters Health Summit in New York on Tuesday.
"You've got something that really works and it doesn't have side effects, and in mass, the experts are truly excited about this," Ishrak said.
"Part of the issue is that it is such a new technology that it is not a conventional plug into the healthcare system. We don't have reach and access to the general practitioners," Ishrak said.
The device, which Ishrak called a "game changer," is still two to three years from gaining approval in the United States. U.S. reimbursement coverage is likely to be determined at the same time the technology gets the green light from regulators, he said.
Millions of people have hypertension that is resistant to drug therapy, putting them at risk for heart attacks and stroke.
That has encouraged several medical technology companies to invest in device-based high blood pressure treatments, which industry analysts believe will eventually develop into a multibillion-dollar market.
Other devices makers that have received approval to sell hypertension devices in Europe include St Jude Medical Inc STJ.N, Covidien COV.N, ReCor Medical and Vessix Vascular.
The new devices work by creating tiny scars along nerves in the kidneys - organs that play a pivotal role in regulating blood pressure by sending signals to the brain that can cause blood vessels to constrict.
The scarring process is carried out by threading a catheter through the renal arteries from the groin. It deadens the nerves and decreases blood pressure.
Ishrak said that while it is taking some time to put reimbursement policies in place, he believes ultimately it will happen. To help make the case for wider adoption, Medtronic is conducting additional studies to demonstrate the value of the therapy in addressing a condition in patients who have no other options.
"This care pathway for managing the patient is still being created," he said. "The fundamental value is there. It's a matter of getting different administrators to decide how it fits."
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(Additional reporting by Julie Steenhuysen; Editing by Michele Gershberg and Bob Burgdorfer)