News | Embolic Protection Devices | February 19, 2018

Sentinel Cerebral Protection System Reaches 50-Center Adoption Milestone in U.S.

Company applying for New Technology Add-on Payment under Medicare hospital inpatient prospective payment system

Sentinel Cerebral Protection System Reaches 50-Center Adoption Milestone in U.S.

February 19, 2018 — Claret Medical announced that since U.S. Food and Drug Administration (FDA) clearance in June 2017, its Sentinel Cerebral Protection System has been adopted by 50 U.S. centers as part of its controlled rollout. The company said that some institutions have adopted the device as an emerging standard of care in the U.S. to protect patients from the risk of stroke by capturing and removing debris associated with transcatheter aortic valve replacement (TAVR) before it travels to the brain. The novel system has been shown to significantly reduce the risk of stroke in the first three days after TAVR by more than 60 percent, according to Claret Medical.

“During the TAVR procedure, we must remember that we liberate a wide spectrum of debris from the hostile aortic arch and the aortic valve complex due to the atherosclerotic nature of this disease. Some of the liberated debris is several millimeters in size, and can travel to the brain and cause ischemic brain damage or stroke, as demonstrated by outcomes from the SENTINEL U.S. and SENTINEL ULM trials,” said Hemal Gada, M.D., of Pinnacle Health, Harrisburg, Pa.

Gada continued, “We have adopted the Sentinel System as the standard of care to protect our patients during every TAVR case, since the occurrence of embolic stroke is unpredictable, devastating and consequential to our patients, their caregivers and the healthcare community at large. Since the introduction of Sentinel in our center in July 2017, we have had significant improvement in neurologic outcomes.”

Gada led a presentation of clinical benefits of the Sentinel System at the February 13, 2018 Centers for Medicare and Medicaid Services (CMS) Town Hall meeting as part of the device’s approval process for gaining a New Technology Add-on Payment (NTAP) under the Medicare hospital inpatient prospective payment system (IPPS).

The company also announced that Stacy Enxing Seng, a 30-year medical technology leader, has joined the company’s board of directors. She is currently a venture partner with Lightstone Ventures and a member of the board of directors for a variety of public and private companies, including The Fogarty Institute for Innovation. Enxing Seng’s experience includes leading Covidien’s vascular division and ev3, as well as a variety of management roles with Boston Scientific, SCIMED Life Systems, Baxter Healthcare and American Hospital Supply.

Sentinel is the first and only FDA-cleared device that captures and removes debris that is dislodged ubiquitously during TAVR before it can travel to the brain and potentially cause neurological and neurocognitive damage, regardless of the TAVR system used or a patient’s risk profile. The SENTINEL IDE trial demonstrated that protected TAVR with the Sentinel results in a greater than 60 percent reduction in the occurrence of periprocedural strokes.

Watch a video on physician perspectives on the 5,000th patient treated with the Sentinel Cerebral Protection System

For more information:


Related Content

DABRA Excimer Laser System Demonstrates Success in Treating PAD
News | Cath Lab | February 27, 2019
Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s...
Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.
Feature | Cath Lab | February 06, 2019
Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufa
Scientists Discover New Heart Attack Repair Pathway

A macrophage immune cell, with a dead cell (pink) that has been eaten, and a mitochondrion (green) between the dead cell and the nucleus. The study’s findings indicate that what the macrophage eats is taken up by the mitochondrion, which in turn communicates with the nucleus to activate the macrophage to promote tissue repair. Image courtesy of Northwestern Medicine.

News | Cath Lab | January 30, 2019
Northwestern Medicine scientists have discovered a novel signaling pathway that promotes healing after a heart attack....
Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy
News | Cath Lab | January 16, 2019
Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE...
National Academy of Engineering, Ohio University Award 2019 Russ Prize
News | Cath Lab | January 03, 2019
Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be...
Videos | Cath Lab | January 03, 2019
This is a walk through inside one of the cardiac hybrid cath labs at the...
Videos | Cath Lab | January 03, 2019
This is the newest cardiac cath lab at the ...
Study Finds Effective Treatment for Coronary Slow Flow
News | Cath Lab | December 27, 2018
Patients who arrive at the hospital with heart-attack-like symptoms have had little recourse for their chest pain if...
Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Overlay Init