ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients.
Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said.
The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device.
Abiomed said that it met with the F...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Patient Monitoring Replacement Heart Valves Abbott Abiomed Medtronic Source Type: news
Can a lifetime guarantee boost value-based care?
Cheryl Bednar, 54, of Laflin, Penn., suffered from chronic pain from hip deterioration until Geisinger Dr. James Murphy performed a hip replacement in February 2018 and offered the lifetime guarantee. (Image from Geisinger)
Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries.
The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes. Medacta a...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Featured Implants News Well Orthopedics Centers for Medicare and Medicaid Services (CMS) Geisinger Health System Medacta Source Type: news
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news
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
GI Dynamics touts results of U.K. study
GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients.
The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract, according to the Lexington, Mass.-based company.
Get the full story on our sister site, Medical Design & Outsourcing.
The post GI Dynamics touts results of U.K. study appeared firs...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Clinical Trials Diabetes Featured News Well Research & Development Surgical Source Type: news
FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.
In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.
Get the full story at our sister site, Drug Delivery Business News.
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Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Source Type: news
Think Surgical, United Orthopedic join forces for global sales
Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system.
Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with clearance anticipated in 2019. The system’s core technology has been used in thousands of total hip and knee replacements worldwide, according to Fremont, Calif.-based Think.
Get the full story on our sister site, Medical Design & Outsourci...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Featured Implants News Well Orthopedics FDA thinksurgical unitedorthopedic Source Type: news
Lessons learned from Lantheus CEO Mary Anne Heino
At MassMedic’s Women in Medtech event last month, Lantheus Medical Imaging CEO Mary Anne Heino spoke with MassDevice.com editor Sarah Faulkner about her career in life sciences, the power of mentorship and the necessity of courage.
When Mary Anne Heino first joined Lantheus Medical Imaging (NSDQ:LNTH) in 2013, she knew admittedly very little about the field of diagnostics.
“I was walking into a company where the average tenure was more than 25 years,” she said. “So these were people who knew what they were doing and had been doing it for so long…I was intent from day one to show tha...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Featured Imaging Wall Street Beat johnsonandjohnson Lantheus Medical Imaging MassMEDIC Source Type: news
Apple touts results from massive AF-detection Apple Watch study
Apple (NSDQ:AAPL) today released data from its 419,297-patient Apple Heart Study, showing that the device is capable of aiding in the detection of atrial fibrillation using its light-sensor based technology.
Results from the study were released today at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans.
The study was designed to test how well Apple’s Watch could identify and prompt clinical evaluations for atrial fibrillation, the Cupertino, Calif.-based company said.
In the study, data was collected from a mobile application using Apple Watch’s photoplethysmography techno...
Source: Mass Device - March 16, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured mHealth (Mobile Health) Apple Source Type: news
FDA ramps up scrutiny of materials in medical devices
(Image by Michael Longmire on Unsplash)
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.
It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series rip...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Cardiovascular Featured Food & Drug Administration (FDA) Implants Materials Testing Metal-on-Metal News Well Oncology Orthopedics Regulatory/Compliance Replacement Heart Valves Stents Surgical Women's Health ani Source Type: news
Report: Boston Scientific looks to lure Irish expats from Australia to fill its roster
In an effort to fill open positions at its Galway, Ireland-based facilities, Boston Scientific (NYSE:BSX) is offering to cover relocation costs for expatriated residents that left for positions in Australia, according to a Connacht Tribune report.
The residents left Galway for Australia during the recent recession, according to the report, leaving a shortage of skilled workers in Ireland.
Due to the shortage, the Marlborough, Mass.-based company has begun head hunting in Australia, looking for senior quality and manufacturing engineers and to fill R&D roles, according to the Connacht Tribune.
Boston Scientific is look...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Boston Scientific Source Type: news
U.K., French regulators probe safety of paclitaxel devices
Taking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease.
Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk of late mortality in people treated with paclitaxel devices compared to bare devices.
Get the full story at our sister site, Drug Delivery Business News.
The post U.K., French regulators probe safety of paclitaxel devices appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Medtronic Source Type: news
Intuitive Surgical wins another indication for da Vinci SP
Intuitive Surgical (NSDQ:ISRG) said today that it won another indication for the FDA for its da Vinci SP robot-assisted surgery device.
Initially cleared in April 2014 for urological procedures, in June 2018 the federal safety watchdog added a clearance for procedures requiring very narrow access from a single small incision. Today the Sunnyvale, Calif.-based company said the FDA added single-port radical tonsillectomy and tongue base resection procedures to the mix.
“Today’s FDA clearance means surgeons can utilize da Vinci SP robotic-assisted surgery to conduct radical tonsillectomy and tongue base resecti...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Robotics Intuitive Surgical Source Type: news
FDA ’ s CDRH reorganization plans to launch next Monday
The FDA this week announced plans to reorganize its Center for Devices and Radiological Health, combining previously separate premarket review, postmarket surveillance and compliance offices and into one “super office” to better monitor products through their total product life cycle.
The changes are slated to begin next Monday and are expected to be completed by the end of September, according to an FDA release.
The FDA said that goal of the reorganization is to “improve organizational efficiencies to better meet public health needs,” commenting that its current system “does not always promot...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Neovasc retains EC Marking after EU surveillance audit
Updated to correct from CE Marking to EC Marking.
Neovasc (NSDQ:NVCN) said yesterday that it successfully completed its 2019 mandatory surveillance audit with its notified body in the European Union.
The Vancouver-based company said that as a result of the successful audit, and its maintenance of the ISO 13485: 2016 certification of its quality management system, it retained its EC Marking certification in the region.
“The quality system surveillance audits enables us to continue to advance our Reducer and Tiara programs by ensuring the safety, effectiveness and fitness for use of our devices, through risk-based eff...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regulatory/Compliance neovasc Source Type: news
