MARLBOROUGH, MA — The beleaguered Lotus heart valve system is not expected to launch in the US market until 2019, according to Boston Scientific officials.
All Lotus valves were voluntarily recalled worldwide in February 2017 because of reports of early release of a pin connecting the transcatheter valve to the delivery system.
In November 2017, the company announced it was able to resolve the early pin release issue but was scrapping plans for a January 2018 US premarket approval filing and European relaunch by first quarter 2018 because of unexpected challenges within the delivery system detected during final testing.
During an earnings conference call today,[1] Boston Scientific chairperson and CEO Mike Mahoney said progress had been made since the November update and that “pending our ability to clear certain technical and regulatory hurdles, our goal is to launch Lotus Edge in the US and European markets in ’19.”
No further details were provided. However, similar remarks were made during a January healthcare conference,[2] where officials said the company remains committed to bringing the valve system to market but will no longer share any interim technical or testing updates.
Boston Scientific officials, however, were quite bullish during both conference calls on the Watchman device, which brought in $250 million in sales in 2017, despite penetrating only about 1% of the eligible patient population. The left atrial appendage closure device received a lift after gaining reimbursement in Australia and a 10.6% increase in its primary diagnosis-related group reimbursement in the United States starting in October 2017.
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