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Source: Mass Device
Procedure: Heart Valve Surgery
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Total 66 results found since Jan 2013.
Micro Interventional Devices wins FDA nod for Permaseal
Micro Interventional Devices said today it won FDA 510(k) clearance for its Permaseal transapical access and closure device.
The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology.
“The FDA market clearance of Permaseal is another tremendous achievement for MID. This exciting development comes fast on the heels of our recent European approval. Sales in Europe are exceeding our early expectations. With the US approval, coming earlier than expected, MID will be initiating ...
Source: Mass Device - July 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Micro Interventional Devices Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 15, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’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.
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5. Biotronik wins CE Mark for Magmaris bioresorbable scaffold
Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease.
Data from the Biosolve-II trial of the ...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Recent TAVR approvals prompt changes to Direct Flow’s Salus trial
Direct Flow Medical said today that recent FDA approvals for transcatheter aortic valve replacements prompted it to make changes to the Salus trial of its own TAVR entry.
Salus, originally aimed at enrolling 1,262 patients, is now expected to enroll a little more than half that number, 648 subjects, the company said. Santa Rosa, Calif.-based Direct Flow is also adding best practices and comparisons to TAVRs that are already on the U.S. market, which include the Sapien line from market leader Edwards Lifesciences (NYSE:EW) and the Medtronic (NYSE:MDT) CoreValve device.
The 30-patient feasibility phase of for Salus in 20...
Source: Mass Device - April 28, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Direct Flow Medical Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’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. Toshiba partners with UCI to study potential brain damage in HS football players
Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 5, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’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. Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Results from the Propel all-comers trial comparing Medtronic‘s Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 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
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 launches CoreValve Evolut R trial in low-risk patients
Medtronic (NYSE:MDT) said yesterday that it launched another clinical trial for its CoreValve Evolut R replacement heart valve, aiming to win an expanded indication for low-risk patients.
The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic valve replacement. It’s the 3rd trial for Medtronic’s TAVR offering since February, when the FDA approved the new investigational device exemption study.
The primary endpoint is all-cause mortality or disabling st...
Source: Mass Device - April 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Source Type: news
Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers.
Broomfield, Colo.-based Colibri is running a 1st-in-human trial of the transcatheter aortic valve replacement it’s developing, a pre-mounted, pre-crimped and pre-packaged device that’s designed to be shipped ready to use, according to its website.
Colibri has said that patients enrolled in the study showed no observed stroke, no pacemaker implantations, virtually no paravalvular leak and a high retained average effective orifice ...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Colibri Heart Valve Source Type: news
FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R
This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”
Earlier this month, the FDA granted an expanded indication for the CoreValve devices for patients with end-stage renal disease and low-grade, low-flow aortic stenosis.
The post FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R appeared first on MassDevice.
Source: Mass Device - February 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Medtronic wins expanded PMA for CoreValve
The FDA cleared expanded indications for Medtronic‘s (NYSE:MDT) CoreValve TAVR devices, now cleared for use in patients with end-stage renal disease and those with low-grade, low-flow aortic stenosis.
Medtronic won approval from the FDA to modify the CoreValve’s labeling in November which included both its CoreValve and CoreValve Evolut R systems.
The changes to the labeling were approved based on Medtronic’s CoreValve U.S. expanded use study of high and very-high-risk subjects at need for aortic valve replacements, according to an email FierceMedicalDevices received from a Medtronic spokesperson.
Data from theÂ...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve.
The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption for the Partner III trial is designed to evaluate the Sapien 3 TAVR in patients with a low mortality risk from open surgical valve replacement, the Irvine, Calif.-based company said.
“If this trial is successful, it will allow heart teams to choose a treatment ap...
Source: Mass Device - January 15, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance 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
Medtronic touts CoreValve TAVR real-world registry data
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve replacement, reporting outcomes in-line with its clinical trials of the device.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study reported a 5.2% rate of all-cause mortality and 2.6% rate of stroke at 30 days. Those rates are consistent with the 6.9% and 5% rates, respectively, from the pivotal trial, Fridley, Minn.-based Medtronic said.
“It is reassuring to see that the profound clinical results in the U.S. CoreValve Pivotal studies were replica...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic Source Type: news
