A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

TriGUARD 3™ Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Device is Designed to Minimize the Risk of Cerebral Damage by Deflecting Embolic Debris Away from Cerebral Circulation during Transcatheter Aortic Valve Implantation and other Transcatheter Heart Procedures

Doctor Nicolas Dumonteil, Interventional Cardiologist, Clinique Pasteur in Toulouse, France notes, “Even with increased operator experience and availability of next-generation TAVI devices, cerebrovascular complications remain at a stable level, but continue to be the most feared and devastating complications during TAVI. ” He added, “Interventional cardiologists are seeking options to avoid cerebral complications for their patients.”

TriGUARD 3™ Cerebral Embolic Protection Device is the only CE Marked product designed to cover and protect all three major cerebral aortic arch vessels. The state-of-the-art Nitinol frame and dome-shaped mesh deflector are delivered transfemorally and designed to “self-position” in the aortic arch.  This design allows the TriGUARD 3™ CEP device to conform to a variety of patient anatomies.

“Taking into consideration the devastating impact of stroke, we are pleased to bring this important technology to patients undergoing any transcatheter heart procedure.  The introduction of the TriGUARD 3™ CEP Device in Europe provides physicians the only commercially available device that is designed to protect all three cerebral vessels.” Stated Chris Richardson, Keystone Heart, President and CEO.

Keystone Heart recently completed the REFLECT Trial (a pivotal randomized trial of the TriGUARD 3™ CEP device).  Keystone Heart is currently finalizing data analysis ahead of the planned marketing application to the US Food and Drug Administration.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Dr. Sachita Shah, Sr. Director, Global Health, Butterfly Network, "Butterfly is proud to continue improving maternal health equity through Phase Two of the largest-scale handheld ultrasound distribution and training ever conducted in Sub-Saharan Africa. South Africa is an emerging market that continues to have disproportionately high rates of maternal mortality and stillbirth. Patients need easier access to antenatal imaging, and clinicians need better capabilities for screening high-risk conditions that lead to disproportionately worse pregnancy outcomes in rural areas in the public sector. Together with CHAI and GUSI, we can tackle this by making ultrasound much more accessible, so high-risk conditions can be identified earlier in care, which is known to improve outcomes.”
The clinical Study will enroll up to 97 patients at up to 12 European investigational sites. Completion of the study is expected this year, and results will support CE mark and pre-market approval submissions reports Vivasure Medical.
Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy