After Drug-Eluting Stents: Making the Heart Smaller and the Market Larger
This article was originally published in Start Up
According to a recent report by Windhover/Medtech Insight, "Emerging US Markets for Myocardial Revascularization, Repair, and Regeneration Products and Technologies," drug-eluting stents achieved sales of $1.2 billion in 2003, and sales are expected to continue to grow at a compound annual rate of 27.5% to $4.1 billion in 2008. But revascularization technologies are only one category that offer grwoth opportunities for medtech companies. Another group of players hopes to address patients trending towards heart failure, as a result of heart scar formation or the death of heart muscle cells following a heart attack. New devices and device-enabled products have the potential to intervene in both of these structural processes in ways that existing heart failure drugs, which are merely palliative, can't. Medtech estimates that two strategies-cell therapies for heart muscle regeneration and remodeling devices for the heart--will serve a market that could grow to almost $190 million by 2008.
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In heart failure, neither drugs nor devices can address a cascade of interrelated biomolecular and hemodynamic processes. These ultimately result in increased heart muscle fatigue, adverse ventricular remodeling, continuing loss of left ventricular ejection fraction, and all the other conditions that have created, in 2006, a heart failure product industry with $2.8 billion in product revenues, according to Current and Emerging Technologies for the Management of Heart Failure in the US, a report recently published by Medtech Insight. Looking to the future, there are currently a number of academic research institutions and biotechnology companies focused on the prophylaxis, containment, and potential reversal of the progression of heart failure with cellular transplants and gene therapy designed to accomplish myocardial tissue repair.
While the greater efficacy of drug-eluting stents (DES) compared to bare-metal stents is widely accepted, over the past year, data has continued to build showing that first-generation DES also have a higher late-stage in-stent thrombosis risk, a complication that can cause death 30% of the time, according to some estimates. The findings of these studies had some physicians at this year's World Congress of Cardiology calling for "an immediate halt to DES overuse." However, most conceded that additional randomized trials will be needed to fully understand the potential risks associated with these devices.