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Source: Mass Device
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Total 28 results found since Jan 2013.
Medtronic touts Solitaire stent retriever data
Medtronic (NYSE:MDT) yesterday touted data presented at the International Stroke Conference on its Solitaire stent retriever from 4 studies. The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain, restoring blood flow and removing blood clots that cause acute ischemic stroke.
The Stratis AIS study evaluated the impact of treatment delays and patient outcomes when patients were treated with the Solitaire stent retriever and intravenous tissue plasminogen activator. Of the 984 enrolled patients, 64% were treated with the device and IV-tPA, while 36% were treated with the stent retriever al...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Neurological Wall Street Beat Medtronic Source Type: news
SanBio touts 1-year data on stem cell transplant for stroke
SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients.
The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients  suffering with chronic impairment following an ischemic stroke.
SanBio presented interim results from the study at the American Congress of Rehabilitation Medicine Conference last week, and claims that the study is the 1st of its kindÂ...
Source: Mass Device - November 4, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Neurological Research & Development Stem Cells SanBio Inc Source Type: news
Report: Boston Scientific pauses Lotus Edge heart valve in Europe
Boston Scientific (NYSE:BSX) is reportedly pausing implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue.
Marlborough, Mass.-based Boston Scientific has implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Matthew Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.”
“In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote today in a note to...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
TCT 2016: Stents, stents, stents on Day 1
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.
Stents took center stage Day1, with a raft of studies covering the latest on the bioresorbable front.
Stents equivalent to CABG
Drug-eluting stents are as effect as coronary artery bypass grafts in treating patients with blocked left main coronary arteries, according to a study that compared Abbott‘s (NYSE:ABT) Xience DES with CABG i...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Stents TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
Keystone Heart touts TriGuard cerebral protection data in TAVR patients
Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions with use of the device.
The TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR or TAVI procedures.
Results come from preliminary study findings of 51 patients who underwent TAVR procedures, Keystone Heart said, and were presented at the PCR London Valves 2016 Conference in London.
“These data, together with previously rep...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Keystone Heart Source Type: news
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
Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device
Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization.
Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial appendage. One of those patients died from complications related to an infection suffered after the device was retrieved.
The 1st-generation Watchman device showed a 30-day embolization rate of 0 to 0.7% in trials, and a post-approval registry calle...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular American College of Cardiology Conference (ACC) Boston Scientific Stroke 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
Medtronic touts Solitaire stent retriever meta-analysis
The Solitare stent retriever Medtronic (NYSE:MDT) acquired for $50 billion last year when it bought Covidien is safe and highly effective when combined with standard care using the thrombolysis drug alteplase, according to a meta-analysis of 4 previous trials of the device.
The transcatheter Solitaire device uses a stent-like device to trap and retrieve a blood clot in the brain in cases of ischemic stroke. Researchers from the 4 trials – Swift Prime, Revascat, Extend-IA and Escape – pooled their data to examine the results from 787 patients, randomized to either thrombectomy with the Solitaire device (401) or stan...
Source: Mass Device - February 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Neurological Vascular Medtronic Stroke Source Type: news
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
Early thrombectomy’s promise Totaled?
The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 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
Boston Scientific's Watchman misses 1 of 2 efficacy goals in PREVAIL trial
Medtech titan Boston Scientific finally unveils the full results from its PREVAIL study, which was the subject of controversy at last year's ACC conference.
Boston Scientific (NYSE:BSX) this week unveiled full results from the PREVAIL clinical trial of the Watchman anti-stroke implant, largely agreeing with earlier reports that the device missed a co-primary endpoint for efficacy.
American College of Cardiology, Boston ScientificNews Well, Clinical Trials, American College of Cardiology Conference (ACC), Cardiac Implants, Conference coverageread more
Source: Mass Device - July 1, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
HRS2014: Devices combat drugs for treatment of AF stroke-risk patients
Researchers say that devices used to close off the heart's left atrial appendage appear as good as anti-coagulation drugs for treating certain patients with an increased risk of having a stroke.
New clinical data continues to suggest that left atrial appendage occlusion devices may pose an improvement over warfarin drug regimens for treating patients at increased risk of stroke, researchers reported today.
Boston Scientific, Coherex Medical, Heart Rhythm Society, St. Jude MedicalNews Well, Cardiac Assist Devices, Cardiac Rhythm Management, Conference coverage, HRS 2014, Strokeread more
Source: Mass Device - May 8, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
