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Source: Mass Device
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Total 237 results found since Jan 2013.
Medtronic touts data from Micra pacer AV algorithm study
Medtronic (NYSE:MDT) late last week released data from a new clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore atrioventricular synchrony and improve cardiac function in patients with sinus rhythm and AV block.
Results from the study were presented at the Heart Rhythm Society’s annual scientific sessions in Boston, the Fridley, Minn.-based company said.
Researchers in the Marvel study examined the use of the algorithm, which uses the Mira pacer’s accelerometer signal, in 64 patients, Medtronic said. Investigators aimed to evaluate whether ...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Medtronic Source Type: news
HRS 2018: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Boston Scientific HRS 2018 Source Type: news
HRS 2018 Roundup: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Apple Bardy Diagnostics Boston Scientific Fitbit HRS 2018 Impulse Dynamics Imricor Medical Systems Inc. medicalgorithmics Medtronic Preventice samsung Source Type: news
HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation
Long-awaited data released today from a large clinical trial comparing catheter ablation with drug therapy in treating atrial fibrillation showed no significant benefit for ablation, according to Dr. Douglas Packer, who presented the findings today at the annual meeting of the Heart Rhythm Society in Boston.
The 2,204-patient trial, sponsored by the National Institutes of Health and industry players Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Johnson & Johnson (NYSE:JNJ) unit BioSense Webster, focused on a primary composite endpoint of total mortality, disabling stroke, bleeding an...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat Cardiac Rhythm Management HRS 2018 Source Type: news
Stryker wins expanded CE Mark for Trevo stent retriever
Stryker (NYSE:SYK) said today that it won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.
The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company, and follows a similar move in February by the FDA.
“Along with the expanded indication in the U.S., this expanded indication for Trevo in Europe marks a significant milestone in the treatment of stroke patients who suffer from this disease,” neurovascular...
Source: Mass Device - May 7, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Regulatory/Compliance Stroke Stryker Source Type: news
Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures.
The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commercialization, ...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news
Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity
We presented positive initial results in Crohn’s disease at the 2016 United European Gastroenterology meeting: six of the eight patients had seen a substantial reduction in their disease activity index scores, and three were in remission from the disease.
As SetPoint looks ahead, several chronic disease areas are emerging as key bioelectronic medicine therapy targets, and our company is exploring a number of these. One of our preclinical programs explores bioelectronic medicine’s potential role as a treatment for MS.
New Target: Multiple Sclerosis
In late 2017, SetPoint presented positive data from a study exp...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Anthony Arnold Tags: Bioelectronic Medicine Clinical Trials Neuromodulation/Neurostimulation SetPoint Medical Sponsored Content Source Type: news
Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients.
The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy.
“With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news
Medtronic touts reduced AF, improved activity in AdaptivCRT studies
Medtronic (NYSE:MDT) today released results from two real-world analyses of its AdaptivCRT algorithm, touting that its use was linked to a reduction in atrial fibrillation episodes and higher patient activity levels.
Results from the analyses, which involved a total of 408 patients at 26 centers in Italy, were presented at the European Heart Rhythm Association’s Scientific Sessions 2018 in Barcelona, Spain, the company said.
Medtronic’s AdaptivCRT algorithm is designed to adjust pacing to the heart dependent upon evaluations of heart rhythm made every minute, the company said. The program has been shown to in...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Software / IT Medtronic Source Type: news
ACC ’ 18 Roundup: Abbott releases long-term HeartMate 3 data
Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.
Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.
More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.
The two-year cohort met its primary endpoint, achieving 77.9% event...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Wall Street Beat Abbott Aetna AliveCor iRhythm Technologies Inc. Jan Source Type: news
ReWalk Robotics inks $20m private placement, posts Q4, 2017 earnings
Shares in ReWalk Robotics (NSDQ:RWLK) have risen today after the company announced a $20 million private placement and posted shrinking losses for the quarter and growing sales for the year with its fourth quarter and 2017 earnings.
The company said it inked an investment agreement with Hong Kong-based Timwell Corporation Limited through which the company will receive $20 million in three tranches through the issuance of 16 million shares at a price of $1.25 per share.
The investment will come in three tranches, with $5 million for an initial 4 million shares in the first, $10 million for 8 million shares in the second an...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat ReWalk Robotics Source Type: news
EBR Systems launches trial for wireless pacer
EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval.
Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle.
The FDA approved the Solve-CRT stu...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news
Mitralign raises $10m
Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million.
The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016.
The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce v...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Mitralign Inc. Source Type: news
FDA clears software using AI to evaluate CT scans for stroke
Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance.
The company’s LVO Stroke platform is designed using deep learning and connects to a hospital CT scanner to alert stroke specialists that a suspected LVO stroke has been identified, with the ability to send radiological images directly to the physician’s phones.
“Timely LVO stroke identification and transfer to a specialist hospital that ...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Software / IT vizai Source Type: news
Penumbra touts non-inferiority in Compass aspiration thrombectomy trial
Penumbra (NYSE:PEN) late last month released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers.
Results from the trial were presented at the International Stroke Conference, the Alameda, Calif.-based company said.
Investigators in the trial aimed to compare the use of Penumbra’s aspiration thrombectomy system, which uses a suction to remove clots, against traditional stent retrievers in treating patients with acute ischemic stroke.
Results from the study indicated 52% of patients treat...
Source: Mass Device - February 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Penumbra Inc. Source Type: news
