Left ventricular devices assist devices (LVADs) offer hope to patients with heart failure and the technology is progressing quickly. But unnecessary requirements by FDA could suppress device innovation and access, says a report from the American Enterprise Institute for Public Policy Research.

January 25, 2011

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Body of Evidence: LVADs Help Prevent Heart Failure

The report, "Are Medical Devices Turning the Corner against Heart Failure?" examines 20 years of data on heart failure treatments and concludes that the latest technology in the form of LVADs hold significant promise and could "mark a transition to a new stage for devices in medical practice.

The report also discusses the complex issues of reimbursement and the high price-tag associated with such devices (more than $100,000, including implantation and post-op care).

"More importantly, the development of LVADs will be constrained by FDA regulation," says the report, calling for faster approvals of such advanced devices. The authors use the example of the European Union's adoption of Throatec's HeartMate in 2005 compared with FDA's approval two years later in 2008. It also says that development of next-generation LVADs is happening much faster in the EU than it is in the United States. Finally, the report recommends that FDA eliminate unnecessary clinical requirements and other hurdles that retard device innovation and access.

We need more such overarching reports of medical device efficacy. AEI has provided a thoughtful, balanced overview of public policy as it relates to the promising technological advances in the medical device sector. The report on LVADs serves as a powerful reminder that balancing safety and access almost requires a case-by-case assessment for medical technology.

—Heather Thompson

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