Earlier this month, Medtronic Inc. (Minneapolis) launched medtech's first direct-to-consumer (DTC) marketing campaign for the cardiovascular sector. Announced with limited details in August, the massive publicity effort is designed to raise awareness of sudden cardiac arrest and the role of implantable cardioverter-defibrillators (ICDs) in preventing death and enhancing the overall quality of life for individuals with serious heart arrhythmias. The campaign includes print, television, and online advertising, augmented by information brochures and a toll-free number for patients. It also includes physician education programs on the use of ICDs. The company will reportedly spend up to $100 million on the marketing initiative.

Medtronic's announcement came just days after FDA asked Congress for permission to impose a new fee on pharmaceutical manufacturers to cover the cost of monitoring DTC drug ads. While medtech DTC advertising efforts are dwarfed by those in the pharma industry, market research firm Cutting Edge Information (Durham, NC) reports that consumer advertising of medical devices reached the $50 million mark in 2005, an increase from virtually nothing in 1996.

The Medtronic campaign is generally seen as an effort to rebuild physician and patient confidence in the cardiac rhythm management (CRM) sector following widely reported safety problems and malfunctions of the devices that resulted in the recall of nearly 200,000 ICDs and cardiac pacemakers. The problem units were manufactured by Guidant, which has since been acquired by Boston Scientific Corp. (Natick, MA). Although Medtronic's ICD sales are recovering, they remain below the rate of growth prior to Guidant's massive recall.

In formally kicking off the DTC effort, Steve Mahle, president of Medtronic's cardiac rhythm disease management division, said, "Today, nearly 1000 Americans will die of sudden cardiac arrest--many of these deaths could have been prevented with ICD therapy. We believe that more can be done to reach the hundreds of thousands of people who we know could benefit from ICD therapy, but remain unprotected. Ultimately, we believe this campaign will help save more lives."

The promotional effort has not yet sparked the kind of controversy that some analysts had anticipated. Although some physicians expressed concern that the decision to implant an ICD should not be made lightly, many were willing to give credit to Medtronic for providing useful and important information about sudden cardiac arrest without undue scare tactics.

Yet Westby G. Fisher, MD, a cardiologist and cardiac electrophysiologist with Evanston Northwestern Healthcare (Evanston, IL), questions whether the campaign might backfire on Medtronic. He says the promotional pitch might pay off in the short term as some doctors enjoy the increased volume of patient visits. "But it might also alienate the very physicians on whom Medtronic relies to recommend its devices, tacitly implying they are incapable of appropriately recommending such therapy to their patients," he says. Fisher says that although Medtronic's commercial and associated materials were probably shown to consumer focus groups prior to airing, he doubts that the campaign was vetted by physicians.

"As the leader in implantable cardiac devices, we believe it's our responsibility to help ensure that those at greatest risk of sudden cardiac arrest are informed about their choices so they can work together with their physicians to determine what's right for them," said David Steinhaus, MD, vice president and medical director of cardiac rhythm disease management at Medtronic.

Other medtech manufacturers of ICDs have not publicly commented on Medtronic's DTC campaign, nor have they disclosed any plans to pursue a similar marketing strategy. Boston Scientific's ICDs are now also rebounding somewhat. Yet, as a result of the Guidant turmoil, the company has ceded the number-two spot to St. Jude Medical Inc. (St. Paul, MN), which also saw its ICD sales pick up during the fourth quarter of 2006. Medtronic remains the market leader with what the company reports is a 57% market share.

Apart from its current DTC effort, Medtronic believes it can grow the ICD market with new models featuring wireless circuitry that will monitor and report device functioning to base stations in patients' homes. In turn, the stations will send the data to patients' doctors through Medtronic's CareLink network. Next-generation ICDs are expected to make use of portable digital devices that will be capable of relaying heart rhythm data to physicians or clinics from anywhere a patient can establish a wireless link.

Medtronic believes that the market for ICDs is still wide open, with less than 35% of potential users presently implanted with the devices. While many analysts take issue with the company's estimate on the size of the market, Medtronic believes it can boost its share by providing better information to physicians and prospective patients while building more technologically advanced devices.

To view Medtronic's television commercial and related promotional materials for its ICD devices, visit www.whatsinside.com.

© 2007 Canon Communications LLC

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