Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates.
The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so.
“In patients undergoing TAVR, use of (the Sentinel) cerebral embolic protection device demonstrated a significantly higher rate of stroke-free survival compared with unprotected TAVR…In addition, there are no safety issues with use of the protection device…Hence, cerebral embolic protection should become standard of care for the TAVR procedure, as there are no pre-procedural independent predictors identified for selection of patients at high risk for stroke,” study authors wrote.
The real-world, all-comers study was conducted at Germany’s University of Ulm and examined a total of 802 consecutive TAVR patients, with 280 of the group protected by the Sentinel.
Patients treated with the Sentinel were reported to have a 2.1% rate of all-cause mortality or all-stroke at 7 days, versus 6.8% for patients not treated with Sentinel.
“Stroke risk with TAVR, although comparable to that with surgical (aortic valve replacement, or AVR), remains to be a serious complication of TAVR…that risk is still in the four to 10 percent range for all strokes, and two to three percent for major strokes. Although this risk is considered ‘acceptable’ when compared with the gold standard therapy of SAVR, the question remains whether such a risk is really acceptable to patients. In the study from Ulm, systematic use of the Sentinel device resulted in a 1.4 % stroke rate…if is performed without an emboli prevention strategy and the patient has a procedural stroke, one could argue that this adverse event could have been potentially prevented with the use of this device…With TAVR advancing to intermediate risk and younger patients, preventing cerebral ischemic events and protecting the brain from embolic burden is crucial,” Dr. Samir Kapadia of the Cleveland Clinic said in a prepared statement.
Patients treated with the Sentinel were also reported to have a lower rate of stroke at 7 days, at 1.4% versus 4.6% for those who went untreated.
No major adverse events associated with the Sentinel were reported, and device placement success was achieved in 99.6% of procedures, Claret said.
“The study adds to the extensive body of evidence covering more than 1,000 patients and demonstrating that Sentinel is safe, removes debris from virtually every patient, and results in significant reduction in early procedural stroke after TAVR. U.S. centers of excellence that have adopted the Sentinel as an integral part of the TAVR treatment algorithm are using it in nearly two-thirds of their eligible patients. Additionally, we have had productive discussions with the Centers for Medicare and Medicaid Services (CMS) about a new technology add-on payment, with the aim of bridging the gap to a future positive DRG classification,” CEO Azin Parhizgar said in a prepared release.
In July, Claret reportedly raised $11.2 million in a new round of equity financing, according to an SEC filing.