Keystone Heart touts TriGuard cerebral protection data in TAVR patients

Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions with use of the device.

The TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR or TAVI procedures.

Results come from preliminary study findings of 51 patients who underwent TAVR procedures, Keystone Heart said, and were presented at the PCR London Valves 2016 Conference in London.

“These data, together with previously reported positive safety, and clinically meaningful outcomes, reinforce the importance of using TriGuard to protect the brain from damage potentially incurred during TAVR procedures. Neurologic damage due to TAVR is overlooked, and protecting the brain has become a priority to improve our patients’ outcomes. Consensus-driven definitions of neurologic measures will facilitate more informed benefit-risk assessments for all procedures and devices, and improve our care of patients,” Dr. Alexandra Lansky of the Yale School of Medicine said in a press release.

Patients treated with the TriGuard embolic deflection device reported a 20% rate of new brain lesion developments, much lower than the 68% of patients who underwent the TAVR system without the TriGuard, Keystone Heart said.

No strokes were reported during the study, Keystone Heart said, and data indicated a 100% rate of successful device placement without interference during the TAVR procedures. The MRI arm of the study reported a “clear improvement” in the mean number of new lesions, mean total lesion time and mean single lesion volume for patients treated with the TriGuard.

Data comes from a study which aims to evaluate the safety and effectiveness of the device in protecting the brain from lesions during TAVR procedures, the company said.

In June, data from a trial of Keystone Heart‘s TriGuard anti-stroke device indicated a lower rate of neurologic deficits after transcatheter aortic valve implantation.

The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to pass through while catching potentially dangerous embolic debris, showed a 3.1% rate of new neurologic deficits at 30 days, compared to 15.4% in patients treated without the device.

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