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ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

3 Reasons TAVR Will Continue to Prosper
The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space. Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic stenosi...
Source: MDDI - January 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Transcatheter Aortic Valve Replacement After Intraoperative Discovery of Porcelain Aorta in a Patient With Aortic Stenosis
PORCELAIN AORTA IS a major risk factor for stroke after cardiac surgery and may prompt alterations in surgical technique.1,2 Transcatheter aortic valve replacement (TAVR) has become a preferred treatment for patients with aortic stenosis and porcelain aorta.2 –4 Although TAVR has become a common procedure worldwide, this procedure typically is characterized by extensive preprocedural planning by a multidisciplinary heart team.5–9 This case conference describes a scenario in which TAVR was performed successfully on an urgent basis after intraoperative discovery of a porcelain aorta in a patient with severe aortic stenos...
Source: Journal of Cardiothoracic and Vascular Anesthesia - August 17, 2016 Category: Anesthesiology Authors: Rohesh Fernando, Jacob T. Gutsche, John G.T. Augoustides, Jeremy D. Kukafka, Warren Spitz, Jonathan Frogel, Michael Fabbro, Prakash A. Patel Tags: Case ConferenceVictor C. Baum, MDSection Editors? > Source Type: research

Edwards Lifesciences hits all-time high on Sapien 3 study
Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend. Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lan...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Wall Street Beat American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news

Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients. Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients). Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news

TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device. The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. Data from all of the CoreValve studies was presented at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco. The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study repo...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic TCT 2015 Source Type: news