Dive Brief:

• Boston Scientific on August 2 announced completion of its purchase of Claret Medical, the maker of the Sentinel embolic-protection device, coming the same day CMS revealed that it would allow a new technology add-on payment (NTAP) for Sentinel. That was a reversal of course after agency officials earlier raised doubts about Claret’s bid for the extra funds.
• CMS made the announcement as part of the fiscal 2019 inpatient prospective payment system for hospitals. In the rule, CMS said Claret estimated the cost of Sentinel at $2,400. Thus, the maximum new technology add-on payment for a  case involving Sentinel will be $1,400 in fiscal 2019, CMS said.
• "The recent CMS NTAP designation underscores the clinical value of the Sentinel System and will allow for accelerated adoption of this adjunctive therapy amongst structural heart centers,” said Kevin Ballinger, Boston Scientific’s president for interventional cardiology, in a statement.

Dive Insight:

Boston Scientific in July announced a deal to acquire Claret Medical for $220 million in up-front cash. The agreement also included an additional $50 million payment pegged to Claret’s bid for the NTAP designation.  Sentinel is intended to capture and remove thrombus and debris during transcatheter aortic valve replacement (TAVR). The FDA cleared the device in June 2017.

Boston Scientific describes Sentinel as “the only device commercially available used to protect patients against the risk of stroke during TAVR.” In an April draft of the IPPS rule, CMS officials were more skeptical about the device. They cited concerns that studies involving the Sentinel cerebral protection system “may be inconclusive regarding whether the device represents a substantial clinical improvement for patients undergoing TAVR procedures.”

“We also are concerned that the SENTINEL studies did not show a substantial decrease in neurological complications for patients undergoing TAVR procedures,” CMS officials wrote in the draft rule.

In the final rule, CMS admitted an error in its initial characterization of certain evidence Claret used to support its application. The agency had said that a meta-analysis of embolic protection (EP) devices, the majority of which included use of Sentinel, found that use of these devices “was associated with a nonsignificant reduction in stroke and death,” CMS noted in the final rule. “After further review, we realize we misquoted the statement made in the study. “

The agency noted that the cited meta-analysis “actually concluded the following: Although the differences in overt stroke were not significant, use of intraoperative EP was associated with a numeric stroke reduction, which may become significant in larger RCTs powered for hard endpoints.” 

CMS officials concluded that data provided by Claret regarding reduced mortality and stroke “demonstrate that the Sentinel Cerebral Protection System represents a substantial clinical improvement.”