Oct 15 2020 The REFLECT II randomised clinical trial evaluating the safety and efficacy of a cerebral embolic protection device TriGuard 3 Keystone Heart in patients undergoing transcatheter aortic valve implantation TAVI found that the device met its primary safety endpoint compared to historical controls but did not demonstrate superiority for the primary
Oct 26 2020 Efficacy Eludes TriGUARD 3 Cerebral Protection Device REFLECT II Monday October 26 2020 Safety goals were met in the trial but better efficacy may require ensuring complete coverage of the three major cerebral vessels. Read More
Interestingly TAVI using CoreValve Medtronic showed more device interference and less stability than SAPIEN 3 TAVI. 16 The Cerebral Protection to Reduce Cerebral Emboli Lesions After Transcatheter Aortic Valve Implantration REFLECT study is currently underway and should provide further insights into Triguard. It randomises TAVI patients 2
Oct 15 2020 Among patients undergoing TAVR cerebral embolic protection with the TriGUARD 3 device was not beneficial. This trial was inconclusive due to early termination of the study however based on the available data cerebral embolic protection was associated with a numerically higher incidence of the composite safety endpoint compared with control.
To evaluate the value of left vertebral artery filter protection in addition to the current filter based embolic protection technology to achieve complete cerebral protection during TAVR. The occurrence of cerebrovascular events after transcatheter aortic valve replacement TAVR has fueled concern for its potential application in younger patients with longer life expectancy.
The TriGuard device is advanced through a 9 Fr arterial sheath that is placed into the contralateral femoral artery and is deployed to cover the ostia of the 3 supra aortic trunks . Its new generation the TriGuard 3 incorporates a design by an over the wire via a 6 Fr femoral sheath .
The REFLECT trial studied the TriGuard device and the next generation TriGuard 3 was studied in REFLECT II. Results have been presented in abstract recently showing the safety of TriGuard 3 but not dem onstrating superiority for the MRI efficacy endpoint.14 Further studies are planned to investigate the clinical efficacy of this device.
The predicate device for the TriGUARD 3 application was the SENTINEL Cerebral Protection System Boston Scientific hereinafter referred to as SENTINEL currently the only embolic protection device commercially available in the U.S. 12for use during TAVR.
Dec 18 2020 There are clinical trials already published showing the efficacy and safety of the device. The DEFLECT I and DEFLECT III trial demonstrated that the technical success which included complete 3 vessel cerebral coverage was achieved in 80 90 of the patients. designed to study the TriGUARD 3 device. The TriGUARD 3 is the new generation
17 hours ago In a meta analysis more than 70 of patients had evidence of silent brain injury after TAVI which was associated with increased incidence of early cognitive dysfunction but still unclear long term effects. 23 Cerebral embolic protection devices reduced the volume but did however not affect the incidence and the number of injuries per patient.
May 23 2019 Efficacy Eludes TriGUARD 3 Cerebral Protection Device REFLECT II Monday October 26 2020 Safety goals were met in the trial but better efficacy may require ensuring complete coverage of
TriGUARD 3 Performance and Cerebral Coverage Full Coverage Throughout 59.3 All devices successfully deployed and retrieved Performance Measures Combined TriGUARD 3 N=157 Successful deployment 100 Successful on 1st attempt 98.1 Technical Success 71 Procedure Success 69.7 Device Interaction 9.6 Deployment Time Mean ±SD 2.81 ± 5.69
Mar 12 2020 Aim To assess the efficacy of the TriGUARD 3 a novel cerebral embolic protection CEP device in reducing cerebral embolization by deflecting embolic debris away from the cerebral circulation using a quantitative in vitro model. Methods and results This in vitro study assessed the ability of a cerebral embolic protection device to deflect embolic debris
Selected cerebral embolic protection devices Company Device Clinical data Status Boston Scientific Sentinel Pivotal trial MACCE rate 7.3 vs 9.9 with control p=0.41 new lesion volume 102.8mm3 vs 178mm3 with control p=0.33 CE marked 2014 FDA cleared Jun 2021 Edwards Lifesciences Embrella Pilot trial total lesion volume 305mm3 vs 180mm3
TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89 of subjects. In this exploratory study subjects undergoing protected TAVI had more freedom from ischaemic brain lesions fewer neurologic deficits and improved cognitive function in some domains at discharge and 30 days compared with
Oct 28 2021 To evaluate the safety efficacy and performance of the TriGuard HDH Embolic Deflection Device TriGuard compared with no cerebral protection in patients undergoing transcatheter aortic valve
Jul 12 2002 One of the most feared complications of transcatheter aortic valve implantation TAVI is stroke with increased mortality and disability observed in patients suffering a stroke after TAVI. There has been no significant decline in stroke rates seen over the last 5 years attention has therefore been given to strategies for cerebral embolic protection. With the emergence
Aug 04 2017 Plans to initiate clinical trials for a new advanced version of the TriGuard cerebral embolic protection device Keystone Heart have been announced. According to the company this third generation device TriGuard 3 will continue the TriGuard legacy of being the only device designed to provide full coverage of all cerebral vessels while protecting the brain
Introduction. Transcatheter aortic valve replacement TAVR has emerged as an alternative to conventional aortic valve replacement CAVR for the treatment of severe aortic stenosis particularly in patients of high or prohibitive surgical risk 1 2 .Despite excellent short term term efficacy outcomes to date for TAVR the associated risk of stroke remains a concern with this
as the delivery of a protection device itself may contribute to embolic events. The TriGuard embolic deflection device is a nitinol frame mesh filter length 88 mm width 25 mm expanded that is placed into the aortic arch before the TAVI procedure. It is folded into a 7 French Mullins sheath which is delivered
TriGUARD 3 cerebral embolic protection device and its efficacy in reducing clinical events and cerebral lesions during transcatheter aortic valve replacement. Keystone Heart TriGUARD 3 TriGUARD HDH n= 141 n= 63 Efficacy Cohort Outcomes of Phase I
Apr 28 2016 First in man use of the new generation TriGUARD 3 cerebral embolic protection device during transcatheter aortic valve implantation. Paradis JM Nazif TM Rodés Cabau J EuroIntervention 14 11 e1178 e1179 07 Dec 2018
Jun 01 2018 Medical devices maker Keystone Heart has started phase II of its Reflect trial assessing the safety and efficacy of its third generation TriGuard cerebral embolic protection device. Image The trial will evaluate the the safety and efficacy of the next generation Keystone Heart –TriGUARD 3 cerebral embolic protection device.
Mousa AY Campbell JE AbuRahma AF et al. Current update of cerebral embolic protection devices. J Vasc Surg 201256 1429 37. Kastrup A Gröschel K Krapf H et al. Early outcome of carotid angioplasty and stenting with and without cerebral protection devices a systematic review of the literature. Stroke 200334 813 9.
Feb 16 2021 The REFLECT Trial Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation Purpose. The Keystone Heart TriGuard HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid subclavian and vertebral arteries during transcatheter heart valve implantation.
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