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SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage.
Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA approved an expansion of the study, which can now enroll another 500 patients after an independent data monitoring committee reviewed the data against preset safety and performance criteria, Redwood City, Calif.-based SentreHeart said....
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Cardiac Rhythm Management SentreHeart Source Type: news
7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Dextera seeks expanded indications for MicroCutter 5/80 stapler
Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news
Finland extends due date on Nexstim R & D loans
Nexstim said today that the Finnish Funding Agency for Innovation has agreed to extend the due date for repayment of 2 of its research & development project loans.
According to the agreement, the company was supposed to provide cash repayments up to €1.8 million ($2 million) between 2017 and 2019. Now, that range has been pushed back to between 2020 and 2022. The company has to fully repay both loans to Tekes by the end of 2023, Nexstim said.
“This agreement, which reschedules our R&D loan repayment payments to Tekes, will have a positive effect on Nexstim’s cash flow and will help to support our workin...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Neurological Wall Street Beat Nexstim Source Type: news
Neural Analytics touts 95% accuracy for TCD platform in Expedite trial
Neural Analytics today released initial results from the Expedite study of its Transcranial Doppler Tech platform, touting 95% accuracy in the early detection of acute ischemic stroke due to large vessel occlusion.
Data from the study was presented at the 26th annual European Stroke Conference this week in Berlin.
The 45-subject trial examined the use of TCD scans in patients experiencing computer tomography angiography confirmed acute ischemic stroke due to large vessel occlusion of the internal carotid artery or middle cerebral artery.
Scans with the TCD platform were analyzed with 2 different stroke assessment algorith...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Ultrasound Neural Analytics Source Type: news
Anaconda Biomed raises $17m for next-gen brain thrombectomy device
Anaconda Biomed said it raised nearly $17 million (€15 million) in a Series A round for the neurothrombectomy device it’s developing.
The round, led by new investors Ysios Capital, Omega Funds and Banco Sabadell and prior backer Innogest Capital, is enough to carry the ANCD Brain device through validation & verification and clinical studies ahead of a CE Mark bid in the European Union, co-founder & CEO Ofir Arad said in prepared remarks.
The proceeds are also earmarked for an initial approval submission to the FDA, Arad said. Ysios general partner Josep Sanfeliu and Omega Funds managing director Claudio...
Source: Mass Device - May 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Funding Roundup Neurological Anaconda Biomed Source Type: news
MassDevice.com +5 | The top 5 medtech stories for May 19, 2017
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. The key components of a well-designed wearable: Sense, analyze, act
One of the earliest uses of a wearable technology was recorded during Emperor Nero’s rule over the Roman Empire from 54 to 68 AD. A brutal leader, the empero...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Slow enrollment delays Nexstim pivotal trial
Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke.
The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said today that “start-up issues” at some of the 5 U.S. sites “created a slight delay in the enrollment rate.”
The E-Fit trial is now slated to be completed during the 2nd quarter of 2018, the ...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Neuromodulation/Neurostimulation Nexstim Stroke Source Type: news
ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts.
The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects.
“It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news
No-touch ’ heart bypass surgery reduces strokes
Four surgical methods of coronary artery bypass grafting with increasing degrees of aortic manipulation. Percentages pictured represent the relative decrease in risk of perioperative stroke using anOPCABG compared to the other techniques. [Image from the researchers]]A recent study from the University of Sydney and Sydney Heart and Lung Surgeons has shown that a new “no-touch” beating heart bypass surgery technique has reduced post-operative stroke by 78%.
The procedure, known as an OPCABG, also reduced post-operative mortality by 50% compared to traditional coronary artery bypass grafting. It reduced renal failure by ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular CABG MedTech Sydney Heart and Lung Surgeons University of Sydney Source Type: news
EuroPCR 2017 Roundup: Boston Scientific ’ s Lotus beats Medtronic ’ s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial.
Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients.
The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary safety endp...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences europcr2017 Medtronic Source Type: news
MassDevice.com +5 | The top 5 medtech stories for May 12, 2017
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. Xtant Medical amends Orbimed credit line to $15m, taps restructuring advisors
Xtant Medical said today that it amended its senior credit line with OrbiMed Advisors, saying it plans to use the $15 million facility to pay off the ...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Boston Scientific touts 1-year stroke reduction results in Watchman non-valvular AF trial
Boston Scientific (NYSE:BSX) today released 1-year results from the Ewolution registry study of its Watchman left atrial appendage closure device, touting a high implant success rate and stroke reduction in patients with non-valvular atrial fibrillation patients.
Data was presented today at the Heart Rhythm Society’s 39th Annual Scientific Sessions in Chicago.
“We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” rhythm man...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.
Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.
The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.
The pr...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials CytoSorbents Corp. Source Type: news
Stable blood sugar linked to heart stent outcomes
Patients with type 2 diabetes and a coronary stent are at lower risk for heart attack and stroke if they maintain good blood sugar control, according to a recent study.
“Although intensive glucose control had no benefit on the rate of major cardiovascular events in previous studies, our data suggest that strict glucose control after PCI (heart catheterization) can improve long-term clinical outcomes in diabetic patients,” Dr. Joo-Yong Hahn from Samsung Medical Center in Seoul said in an interview with Reuters Health.
Researchers looked at 980 patients with type 2 diabetes and a stent, examining long-term bloo...
Source: Mass Device - April 21, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Diabetes Stents Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 19, 2017
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. Intuitive Surgical shares rise on solid Q1 beat
Shares in Intuitive Surgical rose today in after-hours trading after the robotic surgical platform maker posted 1st quarter earnings that beat expectations on the Street.
The Sunn...
Source: Mass Device - April 19, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
