The medical device industry had its last War of the Roses just over five years ago. The battle was a fierce competition within the cardiovascular stent market, driven by emerging drug eluting stent (DES) technology.
J&J was first to market with CYPHER, although many would argue that Boston Scientific won the next battle by taking a majority share of the market with TAXUS. The fallout included litigation, tremendous marketing pressure, and competition for key opinion leader support. It also was the precursor to one of the industry’s most competitive bidding wars over Guidant, a prize eventually won (at a price) by Boston Scientific. In a twist of irony, the deal included a forced divestiture of Guidant’s DES technology which was gladly acquired by Abbott Labs.
Now many of the same players are locked in another showdown. The market? Atrial fibrillation, otherwise known as AF or A-fib. AF-related hospitalizations are predicted to climb to over 3.3 million by 2025, and could become a staggering burden on public health. After age 65, over six percent of people suffer from AF. After age 75, this figure increases to 11 percent. AF also plagues hundreds of thousands of younger patients each year.
Medtronic just this week released late-stage study data shows two catheters it is seeking approval for in the United States work faster than a traditional approach in helping doctors treat forms of AF. Both catheters are approved in Europe and both are currently being reviewed by the U.S. Food and Drug Administration.
Meanwhile St. Jude Medical as received European regulatory approval for its own catheter, with the clinical advantage of being the industry’s first ablation catheter to have a flexible and irrigated tip, which could improve the device’s safety and efficacy. Next up, FDA approval expected sometime next year.
And guess what, Bard, J&J and Boston Scientific are also in the fray with their own competing products. The technology curve centers on cryo catheters (temperature) or RF catheters (radio frequency. Next up will be microwave, ultrasound & laser ablation technologies. Who will win? Too early to tell but the competitive fires are again burning hot within the cardiovascular device sector.
