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4/2/24: Transforming Tricuspid Valve Care: FDA Gives Green Light to Abbott’s TriClip™ - "The U.S. approval of #TriClip is a significant advancement for people suffering from #tricuspidregurgitation, a #heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker." More at https://lnkd.in/esDjzMFT

📃Scientific paper: Transcatheter versus surgical closure of ventricular septal defect: a comparative study Abstract: Background In many countries, surgical closure of ventricular septal defects remains the recommended approach of ventricular septal defect closure. The aim of this study is to compare the safety, efficacy, and clinical effects of surgical versus transcatheter closure of a ventricular septal defect. Methods We conducted a comparative randomized study on patients undergoing ventricular septal defect closure. Patients were allocated to undergo either surgical (group I) or catheter (group II) ventricular septal defect closure. Results Seventy-two patients were included. Operation success was achieved in 100% of the surgical group versus 33 of 36 patients of the percutaneous group (91.6%) ( p value 0.076). There was no significant difference regarding the residual ventricular septal defect. The postoperative echo in group I revealed severe tricuspid regurgitation in one patient (2.7%), and one patient needed a permanent pacemaker. On the other hand, in group II, during the procedure, one patient had severe tricuspid regurge (2.7%). There was a significant difference in the postoperative data favoring group II over group I regarding ventilation duration, intensive care unit stay, total hospital stay, and blood transfusion ( P value < 0.001 each). Conclusion Both transcatheter device closure and surgical repair are effective treatments. In contrast, the psychological profile of the transcatheter device was superior to the surgical repair, especially in terms of avoiding... Discover the rest of the scientific article on es/iode ➡️https://etcse.fr/Hy

On February 13, 2024, the Circulatory System Devices Panel of the Medical Devices Advisory Committee met to make recommendations, and vote on information regarding the premarket approval application (PMA) for the TriClip G4 System by Abbott Medical. The FDA panel took a positive view of TriClip in Tricuspid Regurgitation. The panel recommended TriClip transcatheter edge-to-edge (TEER) device for severe tricuspid regurgitation by citing that the benefits outweighed the risks for the treatment of people with severe tricuspid regurgitation. The panel voted 13-1 that the benefits of TriClip outweighed the risks for use in patients who met the proposed indication criteria. The panel voted 12-2 that TriClip was effective and voted 14-0 that there were reasonable assurances the device was safe. The proposed Indication for Use statement is as follows: The TriClip G4 System is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite being treated optimally with medical therapy, who are at intermediate or greater risk for surgery and in whom tricuspid valve edge-to-edge repair is appropriate as determined by a heart team. The panel reviewed data from the Abbott’s TRILUMINATE pivotal trial and listened to testimony.  TRILUMINATE was an unblinded, open-label trial, and FDA reviewers pointed out that patient-reported outcomes such as the KCCQ score “could be subject to the placebo effect.”  If approved by the FDA, Abbott will have to initiate a real-world, post-approval study, following patients at 30 days and then annually for 5 years. Definitely the 'next big thing'. One more tool for physicians to add to their toolbox. #healthcare #healthcareinnovation #ClinicalTrials #diversityinclusion #diversityequityinclusion #medicaldevices #medicalaffairs #DEI

Big news from Colospan! We've expanded our Intraluminal Bypass Device lineup with additional sizes, offering even more options to patients and surgeons. Our innovative solution offers an alternative approach to diverting stoma, promising enhanced outcomes and improved quality of life for patients. Learn more about this game-changing advancement in our latest press release.

On Feb. 1, the FDA approved the Edwards EVOQUE Tricuspid Valve Replacement System, an artificial heart valve that can be implanted using a delivery catheter without open-heart surgery. The EVOQUE valve is intended to treat patients with severely leaky tricuspid valve (tricuspid regurgitation) - often caused by an enlarged heart or damaged native valve flaps (leaflets) - who continue to experience symptoms despite being on heart failure medications. This approval marks the first transcatheter replacement device indicated for use in the tricuspid position. https://bit.ly/4bBTYhU

#breakingNews: #medicaldevices: Abbott/Thoratec Corporation is recalling #HeartMate II and #HeartMate 3 Left Ventricular Assist System (LVAS). The recall is due to an issue called Extrinsic Outflow Graft Obstruction (EOGO). EOGO happens when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery. This buildup can obstruct the device, making it less effective in helping the heart pump blood. The accumulation of biological material typically occurs over two years or more. The use of affected LVAS may cause serious adverse health consequences and in worst cases, could result in death. There have been 273 reported injuries and 14 reports of death associated with this issue. The devices have been distributed since April 21, 2008, and 13,883 devices have been recalled in the U.S.

📃Scientific paper: Tubeless PCNL versus standard PCNL for the treatment of upper urinary tract stones: a propensity score matching analysis Abstract: Purpose In this study, the feasibility of tubeless percutaneous nephrolithotomy (PCNL) for the treatment of upper urinary tract stones was investigated. Methods From January 2021 to December 2022, the clinical data of 273 patients who received tubeless PCNL (Group A) were studied. The control group includes clinical data from 302 patients (from January 2019 to October 2022) who received standard PCNL (Group B). The baseline characteristics were consistent between the two groups after using the propensity score matching (PSM) method. Compare the preoperative clinical characteristics, postoperative complications, residual stones, catheterization time, and hospital stay between the two groups. Results 146 pairs of patients were successfully paired through PSM. There was no statistically significant difference in operative time, blood leukocyte counts, haemoglobin decrease, fever, urinary extravasation, sepsis, bleeding, blood transfusion rates, embolism, and residual stones after surgery between the two groups; Postoperative day 1 and discharge day, the VAS pain score in Group A was significantly lower than that in Group B. The catheterization time and hospitalization time of patients in Group A were significantly lower than those in Group B. Conclusion According to the inclusion and exclusion criteria, selecting suitable patients for tubeless PCNL is safe and effective, while significantly alleviating pain and reducing catheterization time and hospital stay. Continued on ES/IODE ➡️ https://etcse.fr/reNa ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

🚀 Transforming Carotid Revascularization: TCAR's Rise in the US (2015-2019) 🔬 Study by David Stonko, Earl Goldsborough, Pavel Kibrik, George Zhang, Courtenay Holscher, Caitlin Hicks reveals significant shifts in carotid revascularization techniques. 📊 Key Findings: Analysis of over 108,000 patients from the Vascular Quality Initiative database. Transcarotid artery revascularization (TCAR) use increased remarkably since its FDA approval in 2015. Carotid endarterectomy (CEA) remains common but has seen a decrease in use. TCAR has become increasingly preferred for patients at high risk for stroke and other complications. https://lnkd.in/d-czK2pd #HealthcareInnovation #VascularSurgery #TCAR #MedicalResearch #PatientCare #CarotidRevascularization #cme