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Source: Mass Device
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Total 467 results found since Jan 2013.
Stryker wins FDA HDE nod or Neuroform Atlas wide-neck aneurysm stent
Stryker (NYSE:SYK) said today it won humanitarian device exemption from the FDA for its Neuroform Atlas stent system designed to be used with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms.
The newly HDE-cleared Neuroform Atlas is a nitinol stent designed to be used with metal coils to pack aneurysms in the brain.
The system is positioned through a small tube and delivered across the neck of the aneurysm to support and pack it, the company said. Wide neck aneurysms are estimated to represent less than 10% of unruptured aneurysms treated.
“The Neuroform Atlas Stent System is the mos...
Source: Mass Device - November 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Stents Vascular Stryker Source Type: news
Medtronic wins CE Mark for Intellis SCS, PNS systems
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Intellis spinal cord stimulation and peripheral nerve stimulation systems designed to treat chronic pain.
The Fridley, Minn.-based company touted the Intellis as the world’s smallest fully implantable SCS neurostim. The newly-cleared system includes improved battery performance and is managed through the use of a Samsung Galaxy Tab S2 tablet.
“Medtronic’s goal is to simplify treatment and improve the patient experience with personalized therapy that provides long-term pain relief and helps restore function. The launch ...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Pain Management Regulatory/Compliance Medtronic Source Type: news
TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation.
Five-year data from the Prevail study was published online today in the Journal of the American College of Cardiology.
In both trials, the Marlborough, Mass.-based company compared the Watchman device to warfarin treatment for stroke prevention in patients with non-valvular AF with follow-ups out to five years. A combined an...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.
Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes.
Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver.
Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT.
One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysi...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news
TCT 2017: Abbott ’s Xience coronary stent helps patients feel better faster than open-heart surgery
Abbott (NYSE:ABT) reported today that patients who were treated with the company’s Xience coronary stent for left-main coronary artery disease felt better faster compared to patients who had open-heart surgery.
The data were presented at this year’s Transcatheter Cardiovascular Therapeutics meeting during a late-breaking session.
“For any treatment, it’s important to not only consider clinical outcomes such as recurrent heart attacks or stroke, but also to consider the effect of the treatment on a patient’s quality of life,” study investigator Dr. Suzanne Baron said in prepared remarks.
Get ...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Surgical Wall Street Beat Abbott Source Type: news
Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week.
In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures.
Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device.
The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said.
The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year.
Secondary endpoints in t...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
7 medtech stories we missed this week: Oct. 20, 2017
[Image from unsplash.com]From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention.
1. InspireMD inks Chile distribution deal
InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime Embolic Protection System (EPS). The MGuard Prime EPS treats acute coronary syndromes like acute myocardial infarctions.
2. Medacta launches MiniMed hip stem
Medacta has launched its MiniMAX Hip System in the U.S., according to an Oct. 12 press release. ...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Implants Orthopedics Patient Monitoring Regulatory/Compliance Surgical Ultrasound Esaote Hill-Rom Holdings Inc. Honeywell InspireMD Medacta Source Type: news
Claret Medical raises $21m
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted this week.
The Santa Rosa, Calif.-based company is not seeking to raise any more funds in the round and has not yet stated how it plans to spend the funds it raised.
Money in the round came from 35 anonymous investors, according to the SEC filing, with the 1st sale noted on June 22.
Earlier this week, Claret Medical released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortali...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
Stryker wins $3m tax break for Utah facility expansion
Stryker (NYSE:SYK) has won a $3.4 million tax-rebate incentive from the state of Utah to expand its neurotechnology training and manufacturing center in Salt Lake City, according to a Salt Lake Tribune report.
Kalamazoo, Mich.-based Stryker aims to add 540 people and spend $100 million over the next 10 years as part of the expansion, according to the report.
As part of the tax break deal, workers hired by Stryker will be required to be paid 100% of the average wage in Salt Lake County, resulting in new wages of $192 million and $17 million in state tax revenue, the SL Tribune reports.
“World-class companies like Str...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stryker Source Type: news
Russian study pits InspireMD ’ s CGuard device against Abbott ’ s Rx Acculink carotid stent
InspireMD (NYSE:NSPR) this week touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT).
The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research Institute of Circulation Pathology in Novosibirsk, the study is led by Dr. Andrei Karpenko.
The primary endpoint is new ischemic areas in the brain 24 to 48 hours post-procedure and new lesion permanence at...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Stents InspireMD Stroke Source Type: news
Integra LifeSciences completes purchase of J & J ’ s Codman Neurosurgery
Integra LifeSciences (Nasdaq: IART) has completed its previously announced $1.045 billion purchase of Johnson & Johnson’s Codman Neurosurgery business, the companies announced today.
“The addition of Codman Neurosurgery expands our global leadership position by creating one of the broadest medical device portfolios in the neurosurgery market,” Peter Arduini, Integra’s president and CEO, said in a news release.
“Our planned investments in product innovation and global infrastructure will allow us to provide more healthcare solutions to surgeons and their patients worldwide,” Arduini said.
Integra...
Source: Mass Device - October 2, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well Wall Street Beat Codman Neuro Integra LifeSciences Corp. johnsonandjohnson Natus Medical Inc. Source Type: news
LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae
LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae.
The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles.
Optiflow Arterial cannulae have a “basket tip with large openings,” LivaNova reported, which has been shown to significantly reduce wall shear stress and turbulence. This feature could help lessen ischemic complications from extracorporeal circulation during cardiac surgery, the company sa...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat LivaNova Source Type: news
Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway.
The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow.
Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company.
Edwards has incorporated the taller skirt initially with sizes 20, 23 and 26 mm. A...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news
