UPDATED Feb. 27, 2017, with reaction from Claret Medical.
The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to use a pair of temporary arterial filters during trans catheter aortic valve replacement procedures to trap blood clots before they reach the brain.
Members of the panel said that while current efficacy data on the device was not strong enough to assess its ability to prevent stroke, the device may be worth allowing due to its safety profile and the possible benefits it brings, according to Healio.
Panel members did not take a formal vote in support of the device, but indicated in comments that the data suggested the device would be beneficial to have on the market.
“We were extremely pleased with the near-unanimous recommendation of the committee based on consideration of the totality of the clinical evidence that we have generated over the past 6 years. This strong support was based on the excellent safety profile and ability of the Sentinel CPS to reduce cerebral insults,” president & CEO Azin Parhizgar said in prepared remarks. “The panel provided valuable feedback that will help define future study success criteria in the field of cerebral protection. We look forward to working collaboratively and diligently with the U.S. FDA in the coming weeks to ensure that we can bring the Sentinel technology to American physicians and their patients.”
“The Sentinel device has shown its potential, across multiple trials, to filter and remove brain-borne debris safely, with very few vascular complications,” added clinical steering committee chairman Dr. Martin Leon of Columbia University Medical Center/New York-Presbyterian Hospital. “When we see the size and heterogeneity of the material captured, it is reassuring for me as a practicing TAVR implanter to know that it can be removed from the patient’s vasculature before it reaches the brain.”
In the hearing, panelists considered significant questions about the device, its functionality, how to test for design and efficacy and whether its indications and labeling are appropriate, according to the report.
The company is seeking a de novo pathway for the device based on data from a pivotal trial in high-risk patients, released in November 2016, which failed to meet the primary efficacy endpoint, although it met the primary safety endpoint.
The 360-patient study had a primary efficacy endpoint of reduction in median new lesion volume in protected territories, assessed by MRI at 2 to 7 days, and a primary safety endpoint of major adverse cardiac and cerebrovascular events at 30 days.
Patients were randomized 1:1:1 to either treatment using Sentinel during TAVR and 2 imaging cohorts for TAVR with or without the Sentinel device. The rate of MACCE was 7.3% in both arms that used the Claret Medical device and 9.9% in the control arm, for no statistically significant difference. The rate of all strokes at 30 days was likewise not significantly different at 5.6% in the device arms and 9.1 in the control group. The median total new lesion volume in protected territories was 102.8mm3 for the Sentinel cohorts, compared with 178.0mm3 for the just-TAVR group.
Important confounders included transcatheter valve type and baseline MRI lesion volume (a marker for baseline cerebral disease burden). After adjusting for these factors, embolic protection resulted in reduction of new lesion volume on MRI, but there was no significant improvement in neurocognitive function associated with embolic protection.
Claret filed for FDA clearance in September 2016 for Sentinel, which won CE Mark approval in the European Union in 2013.
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