Left atrial appendage occlusion implants have had a tough time reaching the U.S. market, where medical device makers face a rival much larger than their usual medtech peers. In addition to the obstacles of regulatory review, LAAO device makers must battle with formidable pharmaceutical companies, which they aim to displace as the champions of stroke prevention in patients with atrial fibrillation.
In order to win hearts and minds in U.S. healthcare, device makers such as St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX) must face off against Big Pharma and makers of anti-coagulation therapies, long considered the gold standard in stroke prevention in afib patients.
"This is a bit how I feel about this fight," said Scripps Clinic assistant professor and LAAO defender Dr. Matthew Price during Sunday’s presentation, referring to one of his slides bearing an image of 2 mis-matched boxers duking it out in the ring. "I’m the small boxer for left atrial appendage occlusion and this giant is the oral anti-coagulation space."
Leaders in anti-coagulation drug therapy entirely dwarf their counterparts in left atrial appendage occlusion, speaking in terms of market capitalization and resources needed to conduct "mega-trials" to prove their mettle. Drug makers have the capital to launch trials of 25,000 patients, but those are scales that Boston Scientific and St. Jude Medical, some of medtech’s biggest players, just can’t match.
Left atrial appendage occluders seal away a small pouch in the heart that, in patients with atrial fibrillation, tends to generate blood clots that can then pass into the body and cause strokes. The vast majority of patients are currently treated with life-long regiments of warfarin or other anti-coagulants that help thin the blood and prevent clot formation. LAAOs would seal off the troublesome cardiac appendage and knock out the clot risk, meanwhile reducing or entirely eliminating the need for long-term drug therapy.
LAAOs have proven in previous studies to be non-inferior to warfarin, the most common anti-coagulant in use for afib patients, with device-based therapy generating short-term adverse event rates on par with warfarin and long-term safety that may best anticoagulation therapy, Dr. Price said. Nonetheless, some regulators and researchers are demanding more clinical data that Price said would add little value to the conversation and which holds device makers to a clinical standard that they don’t have the resources to meet.
Device makers have for years been gathering data on their LAAO devices, Boston Scientific for its Watchman implant, St. Jude for its Amplatzer Amulet, which early this year won CE Mark approval in the European Union, and Amulet’s predecessor, the Amplatzer Cardiac Plug. Boston Scientific has estimated in the past that the potential market for LAA procedures may amount to around $500 million by 2017, but those projections are still fuzzy at best, analysts say.