BURLINGTON, Mass., Dec. 17, 2015 /PRNewswire/ -- Decision Resources Group finds that the global structural heart closure device market will grow robustly over the next ten years, driven primarily by strong uptake of endocardial left atrial appendage (LAA) closure for stroke prevention in atrial fibrillation (AF) patients, a fast-growing population. The long-awaited Food and Drug Administration (FDA) approval of Boston Scientific's WATCHMAN device for endocardial LAA closure establishes the market in the U.S., boosts procedure volumes in Europe and lays the groundwork for Japanese approval within the next two years.
Other key findings from the Medtech 360 report entitled "Structural Heart Closure Devices | Global | 2016 | Market Analysis":
- AF clinical guidelines from the American Heart Association and others were updated in 2014, increasing the portion of the AF population eligible for stroke prevention with warfarin. This will increase the eligible patient population for LAA closure because a portion of these patients will have a contraindication for warfarin or will wish to avoid lifelong pharmacotherapy.
- Endocardial LAA closure faces reimbursement challenges. In February 2016, a National Coverage Determination will be set in the U.S. and not all European health systems have sufficient funds for wider adoption of the procedure
- There is still potential for patent foramen ovale (PFO) closure device market growth given St. Jude Medical's expected 2016 FDA approval for the first PFO-indicated closure device. The target patient population for PFO closure is much smaller than what was thought in the past, influenced by consistently poor clinical trial results. Five-year follow-up data of the RESPECT trial at TCT 2015 showed some benefit for stroke prevention, forming the basis of St. Jude Medical's FDA application.
Comments from Decision Resources Group Analyst Erik Bracciodieta, MBiotech:
- "Boston Scientific has invested much time, effort and money in establishing the endocardial LAA closure device market. Interestingly, marketing for this procedure is aimed at both electrophysiologists, who are increasingly exposed to AF patients for ablation procedures, and interventional cardiologists, who want to support their workload as percutaneous coronary intervention (PCI) procedures flatline."
- "A bioresorbable septal occluder is expected to gain CE mark approval in 2016. It is under development by Carag AG, an engineering consulting firm that will sell the rights to the device to the highest bidder. Physician interest in the device is strong and it will be quickly adopted for atrial septal defect closure, even though it will command a premium price over currently available metal devices. It will be interesting to see which big medtech company will seize this opportunity; the most reasonable candidate might be St. Jude Medical because it will want to secure its commanding lead position in the congenital space."
- Erik Bracciodieta has written a blog on the subject, which can be found here.
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