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Source: Mass Device
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Total 467 results found since Jan 2013.
Contego Medical launches Neuroguard IEP trial
Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis.
The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said.
“We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a ...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Contego Medical 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
Stryker closes $664m Entellus Medical buy
Entellus Medical (NSDQ:ENTL) said today it closed its $664 million sale to Stryker (NYSE:SYK), becoming a wholly owned subsidiary of the Kalamazoo, Mich.-based medtech firm.
Plymouth, Minn.-based Entellus, founded in 2006, makes a family of minimally invasive balloon device products, including its flagship Xpress device, that are designed to treat blocked sinuses. Earlier this year it closed the $81 million buyout of Spirox and its Latera absorbable nasal implant.
In the deal, Stryker paid $24 per share for each share of Entellus, paying an approximate $664 million for the company.
As part of the completed merger, Ente...
Source: Mass Device - February 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Otolaryngology Ear, Nose & Throat Entellus Medical Inc. Stryker Source Type: news
Medtronic inks 5-year partnership with Lehigh Valley Health Network
Medtronic (NYSE:MDT) today announced a five-year strategic partnership with Lehigh Valley Health Network looking to develop value-based solutions for patients within the network.
The LVHN serves a total of eight hospitals across seven counties in Northeastern Pennsylvania, Fridley, Minn.-based Medtronic said.
The healthcare network’s partnership with Medtronic will aim to create programs for more than 70 major medical conditions with goals of reducing cost by $100 million and improving outcomes for as many as 500,000 patients.
“This agreement is exciting not only for Medtronic and LVHN, but also for the health...
Source: Mass Device - February 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Hospital Care Medtronic Source Type: news
Penumbra shares rise on Q4, FY2017 earnings beat
Shares in Penumbra (NYSE:PEN) rose today after the medical device maker met expectations on Wall Street with its fourth quarter and fiscal year 2017 earnings results.
The Alameda, Calif.-based company posted profits of $9.1 million, or 25¢ per share, on sales of $96 million for the 3 months ended December 31, seeing a massive swing from the red on the bottom line while sales grew 31.4% when compared with the same period last year.
Earnings per share were well above the 1¢ loss-per-share consensus on Wall Street, where analysts were expecting to see sales of $96 million, which the company met.
For the full year, Penumbra...
Source: Mass Device - February 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Penumbra 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
Perflow Medical closes $12m round to support Stream Net thrombectomy device
Israel-based neurovascular device developer Perflow Medical said it closed a $12 million round of financing to help support its Stream dynamic neuro-thrombectomy net designed for treating acute ischemic stroke.
Funding from the round will support the European commercialization of the company’s first product, the Stream Net device, and a 510(k) submission to the FDA in pursuit of US approval.
Funds will also help support development of two new products based off the company’s Cerebral Net technology platform for aneurysm neck bridging and flow diversion procedures.
The Stream Net device is designed to treat acut...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Neurological perflowmedical Source Type: news
Stryker wins expanded FDA indications for Trevo thrombectomy device
Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared 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.
“The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance for...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Vascular Stryker Source Type: news
Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said.
“With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences 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
NIH inks $5m partnership with PathMaker Neurosystems for MyoRegulator spasticity device
PathMaker Neurosystems said today it signed a $5 million cooperative partnership deal with the National Institutes of Health to support continued development of its MyoRegulator neurostimulation system designed to treat spasticity secondary to stroke.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston and Paris-based company said.
The money comes as part of a four-year grant awarded through the CREATE Devices program which also provides a partnership with the NIH’s National Institute of ...
Source: Mass Device - February 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation PathMaker Neurosystems Inc. Source Type: news
Stryker touts AHA, ASA updated guidelines based on Dawn thrombectomy trial results
Stryker (NYSE:SYK) said last week that the American Heart Association and American Stroke Association updated guidelines on ischemic stroke based on evidence from the company-sponsored Dawn trial of its Trevo thrombectomy device.
The new recommendations shift the treatment window from six to 16 hours and state that treatment could be a reasonable course of action for up to 24 hours after a stroke, the Kalamazoo, Mich.-based company said.
“We are excited to see that the hard work and results from the Dawn trial are being embraced by the AHA. My colleagues and I are looking forward to the opportunity to improve the l...
Source: Mass Device - January 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological Vascular American Heart Assn. American Stroke Assn. Stryker Source Type: news
J & J ’ s Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus division this week announced the launch of its Galaxy G3 Mini embolic coil and released data from a study of its Embotrap device designed to remove clots from the brain following ischemic stroke.
The Galaxy G3 Mini coils are designed to be approximately 25% softer than the Galaxy G3 xsft coils, with an ultra-low coil profile and a primary wind diameter of 0.009 inches, which Cerenovus said is the lowest profile available in its Spectra line.
The newly launched coil is designed to have a random complex shape to make it comformable and enable the device to seek and fill open...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Clinical Trials Neurological Vascular cerenovus johnsonandjohnson Source Type: news
