Medtech is not immune to the product lifecycle: uptake of new devices starts slowly, accelerates as positive clinical evidence is published, booms as it penetrates needy patient populations, plateaus as the backlog of patients is exhausted, flattens, and one day declines as it is replaced by new technology.
Different structural heart devices, namely heart valves, defect occluders, and left atrial appendage (LAA) occluders are all in different parts of this cycle. Each can be thought to be in a different season, enjoying the boon days of summer, the deathly cold of winter, or some point in between.
Early Spring: After six years and three expert panels Boston Scientific earned the first ever FDA approval of an endocardial LAA closure device, WATCHMAN in March. It’s an umbrella-like device implanted in the LAA of atrial fibrillation patients to prevent stroke. It has sparked huge physician interest in managing the LAA, especially since it means patients don’t have to take anticoagulation drugs like warfarin for the rest of their life. This market is expected to boom in the coming years.
Late Spring: Transcatheter aortic heart valves have been FDA approved since 2013 and have transformed the heart valve market, once the sole purview of surgeons. Interventional cardiologists are eager to uptake this procedure, expanding their patient population as more evidence gathers showing its equivalency to surgery.
Late Summer: Congenital heart defect closure devices are a small market, but it has consistently made a tidy sum for its lead competitor, St. Jude Medical. The market may be slipping into Fall since the birth rate is declining in many developed markets, reducing the patient population. With the potential of a bioresorbable septal occluder gaining CE mark approval in the near future, traditional metal implants will slip into cooler times. Hope lies in accessing underserved patient populations in emerging markets, thus turning back time and preventing the slide into Fall.
Fall: As mentioned in Spring, surgical heart valves are slowly being replaced by transcatheter heart valves. The market for mechanical surgical valves is definitely in the coolest part of Fall, having already been edged out by xenograft tissue valves. Now surgical tissue valves are being edged out by their transcatheter counterparts.
Winter: Patent foramen ovale (PFO) closure devices have suffered time and again for the past few years. The PFO is a hole with a flap in the atrial septum found in about 25% of adults. It’s thought to enable strokes that have no obvious cause by allowing clots to travel from the right to the left side of the heart. PFO closure for stroke prevention trials have failed to meet their primary endpoints, and as such there is no FDA-approved device. Last year, the American Heart Association saw this and downgraded their PFO closure recommendation. One company, NMT Medical, banked their future on this technology and went bankrupt in 2011. Companies have also tried to show the efficacy of PFO closure for migraine, but trials for this have also failed to meet their primary endpoint. Needless to say, this is the coldest time for PFO devices. However, there is hope on the horizon since St. Jude Medical hopes to secure FDA approval next year with secondary analysis from their stroke trial, meaning a spring thaw for this market.
Follow Erik Bracciodieta on Twitter at @ErikB_DRG for additional medtech market insights.