+5 | The top 5 medtech stories for September 19, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve Edwards Lifesciences said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement. The expanded indication covers patients at intermediate risk for open heart surgery, Irvine, Calif.-based Edwards said. Last month the FDA also expanded the Sapien 3 indication to include intermediate-risk aortic stenosis patients. The device won its original CE Mark approval back in January 2014, with the U.S. federal safety watchdog following suit in June 2015. Read more 4. Gore launches trial for Tag thoracic branch endoprosthesis W.L. Gore &Assoc. said today that it enrolled the 1st patient in a pivotal study evaluating its Tag thoracic branch endoprosthesis as a treatment for lesions of the aortic branch and descending thoracic aorta. The Tag TBE is the 1st Gore device to win the FDA’s expedited access pathway designation and among the 1st medical devices in the U.S. to do so, the Phoenix-based company reported. It&...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news

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Authors: Parikh PB, Bloom MW, Pyo R, Patel N, Scott B, Stergiopoulos K, Tannous H Abstract This case illustrates that transfemoral transcatheter aortic valve replacement is safe and feasible in patients with bicuspid aortic stenosis with extremely large annulus and concomitant severe left ventricular dysfunction. PMID: 32610279 [PubMed - in process]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
We describe a cut-down method that is useful in cases with calcification restricted to the region surrounding the puncture site in transcatheter aortic valve implantation patients with severe aortic stenosis. PMID: 32610275 [PubMed - in process]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
We present a case of a 41-year-old male (body surface area, 2.3 m²) who presented 4 months after SAVR with a 21 mm surgical valve (Magna Ease, true inner diameter, 19 mm) with severe PPM (mean gradient, 43 mm Hg) despite normal functioning valvular prosthetic leaflets, associated with debilitating symptoms. This patient was deemed high risk by the heart team, and was successfully treated with TAV in SAV (26 mm Evolut R) and concomitant high-pressure bioprosthetic valve fracture (BVF) with a 22 mm high-pressure balloon. The patient tolerated the procedure well; mean gradient was 5 mm Hg post BVF and prompt resolution o...
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
Authors: Lampert J, Finn MT, Kantor A, Akkoc D, Chen S, Brandwein R, Fidlow K, Liao M, Khalique O, Hahn RT, Vahl TP, George I, Kirtane A, Leon MB, Kodali SK, Nazif TM Abstract OBJECTIVES: The minimalist approach to transcatheter aortic valve replacement (TAVR) focuses on avoiding extraneous invasive measures. Data describing the clinical impact of routine indwelling urinary catheter (IUC) in TAVR patients is limited. We sought to examine outcomes after IUC placement in patients undergoing TAVR. METHODS: We performed a retrospective analysis of 773 consecutive patients undergoing TAVR between 2011 and 2015. Pati...
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
This study aimed to fill that gap. METHODS: Time to cross the valve (TTCV) was measured prospectively in 35 consecutive patients undergoing transcatheter AV replacement and used to define two groups (≤60 seconds or>60 seconds). TTCV was analyzed as a function of 20 imaging variables. The AV was crossed systematically with a pigtail catheter parked in the non-coronary cusp, AL-1 catheter above the AV, and a straight wire for crossing, in 20° left anterior oblique view, as the operator adjusted catheter-to-catheter (CTC; AL-1 to pigtail) and catheter-to-wire (CTW; pigtail to wire) with each failed pass. RES...
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
EFFECT OF SUN EXPOSURE DURATION ON CYCLOOXYGENASE-2 EXPRESSION IN THE CONJUNCTIVA. Acta Clin Croat. 2019 Dec;58(4):639-646 Authors: Reisz Majić P, Cerovski B, Majić P, Krković I, Barać J, Bradvica Štenc I Abstract Pterygium is a multifactorial proliferative pathologic change of bulbar conjunctiva. The purpose of this study was to determine the effect of the duration of exposure to solar radiation (expressed in years) on the incidence of positive cyclooxygenase-2 (COX-2) finding in conjunctival tissue in two groups of patients. Group 1 consisted of 68 patients with primary pterygium having un...
Source: Acta Clinica Croatica - Category: General Medicine Tags: Acta Clin Croat Source Type: research
Publication date: August 2020Source: IJC Heart &Vasculature, Volume 29Author(s): Yuki Kamo, Shinichiro Fujimoto, Chihiro Aoshima, Yuko O. Kawaguchi, Yui Nozaki, Ayako Kudo, Daigo Takahashi, Kazuhisa Takamura, Makoto Hiki, Nobuo Tomizawa, Kanako K. Kumamaru, Shigeki Aoki, Hiroyuki Daida
Source: IJC Heart and Vasculature - Category: Cardiology Source Type: research
Condition:   Aortic Valve Disease Intervention:   Procedure: Aortic valve replacement Sponsor:   Centre Hospitalier La Chartreuse Completed
Source: - Category: Research Source Type: clinical trials
Authors: García Caride S, Cuiña Sardiña R, Perucho González L Abstract The case is reported of a 59-year-old woman, who reported decreased visual acuity (VA) in the left eye (LE). On examination, a corrected VA of finger count/ 30cm was observed in LE. Corneal oedema and folds in the Descemet's membrane were observed using the slit lamp. Anterior synechiae, iris atrophy, and corectopia were also found. Iridocorneal endothelial syndrome (ICE) was diagnosed. The treatment option was a combination of cataract surgery and automated endothelial keratoplasty with Descemet's membrane dissection...
Source: Archivos de la Sociedad Espanola de Oftalmologia - Category: Opthalmology Tags: Arch Soc Esp Oftalmol Source Type: research
Publication date: Available online 30 June 2020Source: American Heart JournalAuthor(s): Helene Eltchaninoff, Nikolaos Bonaros, Bernard Prendergast, Fabian Nietlispach, Mariuca Vasa-Nicotera, Alaide Chieffo, Philippe Pibarot, Peter Bramlage, Lenka Sykorova, Jana Kurucova, Jeroen J. Bax, Stephan Windecker, Nicolas Dumonteil, Didier Tchetche
Source: American Heart Journal - Category: Cardiology Source Type: research
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