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Archive for the ‘Stent Retriever in endovascular thrombectomy’ Category

Paul G. Yock, Recipient of the 2024 National Medal of Technology and Innovation, Professor of Cardiovascular Medicine at Stanford Medical School

Curator: Aviva Lev-Ari, PhD, RN

NMTI Citation

Paul G. Yock, Stanford University 

For innovations in interventional cardiology. Paul Yock’s visionary work understanding the human heart is applied around the world today to improve patient care and save countless lives. His creation of the Biodesign approach to training future leaders of biotechnology and health care ensures his insights and experience will benefit generations to come.

SOURCES

https://www.uspto.gov/about-us/news-updates/2024-national-medal-technology-and-innovation-laureates-honored-white-house

National Medal of Technology and Innovation (NMTI)

https://www.uspto.gov/learning-and-resources/ip-programs-and-awards/national-medal-technology-and-innovation-nmti

Recipients of the 2024 National Medal of Technology and Innovation, administered by President Joe Biden and Laureates of the National Medal of Science, administered by NSF

https://pharmaceuticalintelligence.com/2025/01/13/recipients-of-the-2024-national-medal-of-technology-and-innovation-administered-by-president-joe-biden-and-laureates-of-the-national-medal-of-science-administered-by-nsf/

 

Paul Yock – The Martha Meier Weiland Professor in the School of Medicine and Professor of Bioengineering, Cardiovascular Medicine, and (by courtesy) of Mechanical Engineering

Scientific Leadership Council Member, Clark Center Faculty

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Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Reporter: Aviva Lev-Ari, PhD, RN

 

The stent retriever from Stryker was cleared for thrombectomy-eligible patients as initial therapy to reduce paralysis and other stroke disability only as an addition to tissue plasminogen activator (tPA). Previously, the device was approved only for use within 6 hours of ischemic stroke onset.

 

FDA Clears Trevo Stent Retriever for Up to 24 Hours Post-Stroke

FDA move follows expanded stroke thrombectomy guidelines

by Nicole Lou, Reporter, MedPage Today/CRTonline.org

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, in a statement. “Healthcare providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

The American Heart Association and American Stroke Association recently revised their guidelines to recommend stent retriever use up to 24 hours after symptom onset. This was announced at the International Stroke Conference in January, where the DEFUSE 3 trial added to the evidence from DAWN in demonstrating benefits to relatively late endovascular thrombectomy.

In particular, DAWN data were used to support the FDA’s latest decision. Trial investigators had reported more functional independence when patients were randomized to Trevo thrombectomy over medical management alone.

SOURCE

https://www.medpagetoday.com/cardiology/strokes/71183

 

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

For Immediate Release

February 15, 2018

Summary

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

Release

The U.S. Food and Drug Administration today cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients. This device is cleared for use as an initial therapy for strokes due to blood clots (also known as an acute ischemic stroke) to reduce paralysis, speech difficulties and other stroke disabilities and only as an addition to treatment with a medication that dissolves blood blots called tissue plasminogen activator (t-PA). The device was previously cleared for use in patients six hours after symptom onset.

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, Ph.D., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S. and is a major cause of serious disability for adults. About 795,000 people in the U.S. have a stroke each year. Ischemic strokes represent about 87 percent of all strokes.

The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today’s expanded indication increases the amount of time that the device can be used once the symptoms are present.

Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the blood clot. When the shaped section at the end of the device is fully expanded (up to three to six millimeters in diameter), it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through a catheter or sheath.

The FDA evaluated data from a clinical trial comparing 107 patients treated with the Trevo device and medical management to 99 patients who had only medical management. About 48 percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke compared to 13 percent of patients who were not treated with the Trevo device.

Risks associated with using the Trevo device include a failure to retrieve the blood clot, embolization (blockage) to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral (thigh) artery entry point.

Trevo was reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The FDA granted premarket clearance of the Trevo device to Concentric Medical Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm

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TCT: Stent Complication Rare but Deadly

Reporter: Aviva Lev-Ari, PhD, RN

 

See on Scoop.itCardiovascular and vascular imaging

SAN FRANCISCO — Intraprocedural stent thrombosis is rare during percutaneous coronary intervention, but it strongly predicts adverse events over the next month, a sub-analysis of the CHAMPION-PHOENIX…

See on www.medpagetoday.com

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