Medtronic is hoping that the immediate U.S. launch of its newly approved Revo MRI SureScan MRI-compatible pacemaker will help boost market share in the device category, but magnetic resonance imaging scans of implant recipients still face a key reimbursement hurdle.

Revo’s PMA approval, announced Feb. 8, makes it the first pacemaker available in the U.S. designed specifically for use in the magnetic resonance imaging environment. “Shipments of Revo MRI will begin immediately,” the firm said.

The approval follows a unanimous FDA panel approval recommendation in March 2010. (See “ Also see "Medtronic Hopes For Speedy U.S. Launch Of Revo MRI-Friendly Pacer" - Medtech Insight, 29 March, 2010. ” – “The Gray Sheet” March 29, 2010.)

The U.S. debut could help Medtronic gain an additional 5%-10% of the pacemaker market – Morgan Stanley analyst David Lewis

Under CMS’ current policy, however, MRIs are not covered for Medicare patients with pacemakers. In a September 2009 decision memorandum, the agency had indicated that it would be willing to review related data once FDA approved a pacemaker as safe for the MRI environment.

“CMS has indicated it would review data on the device following approval, which suggests reimbursement is possible in 2011,” Morgan Stanley analyst David Lewis notes in a Feb. 8 report.

In CMS’ September 2009 decision memorandum, the agency declined a request from Medtronic to permit coverage for MRI procedures in patients with pacemakers that have been FDA-approved for use in an MRI environment. CMS claimed at the time that the evidence “is not adequate to conclude that the use of magnetic resonance imaging improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers.” (See “ MRI Coverage Decision ” – “The Gray Sheet” Oct. 5, 2009.)

In December 2010, CMS issued a proposed national coverage decision memo recommending MRI coverage for pacemaker patients only if performed as part of an appropriate clinical trial; the agency plans to issue a final decision on the topic by March 1. (See “ Also see "Medtronic, St. Jude Ask CMS To Ease Restrictions On MRI-Cardio Trials" - Medtech Insight, 10 January, 2011. ” – “The Gray Sheet” Jan. 10, 2011.)

Shipments of the Revo MRI SureScan pacemaker began immediately following PMA approval. (Photo: Medtronic)

Shipments of the Revo MRI SureScan pacemaker began immediately following PMA approval. (Photo: Medtronic)

Medtronic says it remains in communication with CMS about the MRI reimbursement issue. However, Medicare will still cover the actual pacemaker implant under its current policy, Medtronic spokesperson Wendy Dougherty told “The Gray Sheet.”

Revo will be priced at a level “comparable to other pacemakers,” which range from $5,000 to $10,000, Dougherty said.

The Revo MRI SureScan system, with its two accompanying CapSureFix MRI leads, is considered “MR-conditional,” a term used to indicate that a device may be used in the MRI environment under certain conditions, Medtronic explains. The MRI scan is limited to “certain patients, certain parts of the body, and certain scanning parameters,” FDA notes.

For example, eligible patients must have no previously implanted devices or leads, and MRI systems with a static magnetic field of 1.5 Tesla must be used. Patients also must be positioned specifically within the MRI machine so that the center of the MRI bore “is superior to the C1 vertebra or inferior to the T12 vertebra.”

The pacemaker includes a function that is turned on before a scan to prepare patients for the MRI.

Value Of MRI Creates Market Opportunity

The value of an MRI-compatible pacemaker is evidenced by the diagnostic value of the imaging technique and the fact that about 200,000 U.S. pacemaker patients each year currently must forego MRI scans on account of their implant, according to Medtronic. MRI scans “are critical for making a wide range of health diagnoses,” the firm points out.

Patients with non-MRI-compatible implants “could face serious complications if they were exposed to the powerful magnetic fields generated by MRI machines,” the company explains. Such complications could include disruption of settings and overheating of wires, which could result in unintended heart stimulation, electrical failure or tissue damage, according to FDA.

MRI compatibility could help Medtronic further boost its leading 51% share of the roughly $3.7 billion worldwide pacemaker market, analyst Lewis states. Aided by the U.S. market launch, Medtronic could gain an additional 5%-10% of the market at the cost of rivals including St. Jude Medical (33%) and Boston Scientific (16%), according to Lewis.

However, the rival firms also are working on MRI-compatible pacemaker technology, and Lewis forecasts that Boston Scientific and St. Jude Medical will reach the U.S. market “in 2013-2014.”

St. Jude performed its first implant of the Accent MRI-compatible pacer and Tendtril MRI pacing leads in South Africa on Feb. 8, Eric Fain, president of St. Jude’s CRM business, revealed during a Feb. 4 investor call. The company hopes to gain CE mark clearance overseas by the end of March and envisions launching a U.S. study in the second half of 2011.

Meanwhile, pacemaker firm Biotronik gained a CE mark last March for its Evia MRI-friendly pacemaker and accompanying Safio-S lead, and the firm said it is talking with FDA about the approval process.

Medtronic already markets MRI-compatible pacemakers overseas, including the first-generation EnRhythm and second-generation Advisa systems.

Post-Market Study To Include 1,800 Patients

FDA is requiring Medtronic to conduct a five-year, 1,800-patient post-market study of Revo in a larger, more heterogeneous patient population than was originally included in pre-market studies.

While Medtronic proposed the post-market study prior to the FDA panel review, the firm says it has worked closely with FDA to develop the study protocol. The firm plans to provide progress reports to FDA every six months.

Medtronic also will be required to focus on awareness, education and training for cardiologists and electrophysiologists, through the use of brochures, presentations, jobs aids and manuals, as well as other learning tools available via the web.

The post-market study and detailed training had been recommended by FDA’s Circulatory System Devices panel last March.

FDA’s approval was supported by a clinical trial of 484 patients, of which 464 were successfully implanted with the device. Of the 211 patients who were randomized to receive an MRI scan, none experienced MRI-related complications, FDA noted in announcing the approval.

The approval action came despite the fact that Medtronic has yet to fully resolve a 2009 warning letter related to the firm’s Mounds View, Minn., manufacturing facility, which was “unexpected,” analyst Lewis notes.

“We are continuing to work with FDA toward a final resolution to the Mounds View warning letter and are optimistic that we are making progress toward this goal,” Medtronic noted in its Feb. 8 approval announcement. The firm previously had indicated that FDA deemed its responses to the warning letter to be adequate.

By Mark Hollmer

Medtronic Revo MRI Pacer Approved, But Still Faces Reimbursement Hurdle

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