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TVA Medical wins CE Mark for EverlinQ 4 endoAVF
TVA Medical said today it won CE Mark approval in the European Union for its EverlinQ 4 endoAVF system designed for creating hemodialysis access using an endovascular approach. The Austin, Texas-based company said the system consists of 2 magnetic catheters which are inserted into an artery and vein in the arm and use a small amount of radiofrequency energy to connect both to create a fistula. The catheters are then removed and the brachial vain is coil-embolized for future dialysis. “The new system with smaller profile catheters and radiopaque visual indicators was extremely easy to use. This new approach streamline...
Source: Mass Device - September 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Vascular TVA Medical Source Type: news

Cerus wins CE Mark for Contour neurovascular aneurysm system
Cerus (NSDQ:CERS) said today it won CE Mark approval in the European Union for its Contour neurovascular system designed for treating intra-cranial aneurysms. The Fremont, Calif.-based company said the Contour system is designed with a fine mesh braid deployed at the neck of an aneurysm sac to provide both flow diversion and flow disruption. Cerus said it intends to initiate a controlled rollout of the device in select markets in the EU during the 3rd quarter of this year. “The evolution of aneurysm treatment, from surgery, to endovascular coils, to mesh baskets, has created new modalities that are less invasive...
Source: Mass Device - July 7, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Vascular Cerus Corp. Source Type: news

Terumo launches Mirasol pathogen reduction tech trial
This study is intended as a step towards improving transfusion therapy and transfusion safety in the U.S. We’re excited to be a part of this study that hopefully will lead to measures that could further protect the nation’s blood supply from certain complications and threats of blood transfusions,” Miplate lead investigator Dr. Sherrill Slichter of Bloodworks Northwest said in a prepared statement. The study is expected to take 3.5 years and will include involvement from up to 15 hospitals and blood centers as well as 556 patients, the company said. Eligible patients in the trial will have a pla...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Terumo Source Type: news

Terumo ’ s MicroVention touts low adverse composite outcomes in HydroCoil study
Terumo Corp. (TYO:4543) subsidiary MicroVention today released results from a study of its HydroCoil embolic system, touting that the trial met its primary and secondary endpoints and showed low adverse composite outcomes. The 513-patient prospective, randomized, controlled trial aimed to explore the use of the HydroCoil embolic system for treating endovascular aneurysms compared to bare platinum coils, the Tustin, Calif.-based company said. “The results of the Great randomized trial demonstrate the efficacy of aneurysm treatment using our hydrogel coils and are aligned with the results of other clinical st...
Source: Mass Device - March 7, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular MicroVention-Terumo Inc. Source Type: news

Balt International buys Blockade Medical
European medtech firm Balt International said today it acquired endovascular device developer Blockade Medical for an undisclosed amount. The acquisition is part of Balt’s ongoing strategy to bolster its neurovascular portfolio as well as efforts to develop a presence in the U.S., the company said. “This acquisition is a first strategic move towards transforming Balt into an integrated global neurovascular device company. Balt is recognized as a 1st mover in the market thanks to a world-class R&D team, which has proven its ability and rapidity to develop blockbuster products such as the Leo stent,...
Source: Mass Device - September 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Mergers & Acquisitions Neurological Vascular Balt International Blockade Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for July 6, 2016
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. Lombard expands EU launch of Altura AAA endograft system Lombard Medical Technologies said today it expanded the European launch of its Altura endovascular stent graft to the Netherlands and Spain, touting 4 completed procedure...
Source: Mass Device - July 6, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtech approvals: FDA releases September 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015: Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 53 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 31 Total On Hold: 24 Summary of PMA Supplements Under Review Total Under Review: 611 Total Active: 461 Total On Hold: 150 Summary of All PMA Submissions Originals: 3 Supplements: 84 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 53 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 127.6 FDA Ti...
Source: Mass Device - November 16, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time:...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 9...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Clot removal device dramatically improves outcomes for people with acute ischemic stroke
A new device to remove obstructing blood clots can significantly improve outcomes for people who suffer a certain type of stroke, according to a study led by a UCLA investigator. In patients with acute ischemic stroke — in which a clot blocks the blood supply to part of the brain — who received a clot-busting drug, removing the obstructing blood clot with a stent retriever device significantly reduced post-stroke disability and increased the percentage of patients who were independent in daily function after three months. The findings represent the first new treatment for acute ischemic stroke in 20 years, sinc...
Source: UCLA Newsroom: Health Sciences - April 17, 2015 Category: Universities & Medical Training Source Type: news

EndoShape raises $6.8M for vascular plugs and coils
EndoShape is raising $6.8 million in support of its minimally invasive technologies for occluding blood vessels. EndoShape is in the process of raising $6.8 million in the latest reported funding round for the minimally invasive vessel occlusion devices maker. EndoShape Inc.News Well, Coil Embolization, Endovascular, Funding Roundup, Vascular Closureread more (Source: Mass Device)
Source: Mass Device - June 20, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news

Endovascular Treatment of Unruptured Cerebral AneurysmsEndovascular Treatment of Unruptured Cerebral Aneurysms
This study compares in-hospital outcomes of endovascular coiling with and without adjunctive stenting for unruptured cerebral aneurysms. Did stenting increase risk of complications? Journal of Neurointerventional Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 16, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news

Growth, not just size, boosts brain aneurysms' risk of bursting
Brain aneurysms of all sizes — even small ones the size of a pea — are up to 12 times more likely to rupture if they are growing, according to a new UCLA study.   Published July 2 in the online edition of the journal Radiology, the discovery counters current guidelines suggesting that small aneurysms pose a low risk for rupture, and it emphasizes the need for regular monitoring and earlier treatment.   "Until now, we believed that large aneurysms presented the highest risk for rupture and that smaller aneurysms may not require monitoring," said lead author Dr. J. Pablo Villablanca, chie...
Source: UCLA Newsroom: Health Sciences - July 2, 2013 Category: Universities & Medical Training Source Type: news

Coiling versus Clipping for Unruptured Intracranial AneurysmCoiling versus Clipping for Unruptured Intracranial Aneurysm
The authors perform a systematic review and meta-analysis comparing the benefits and risks of treating unruptured intracranial aneurysms with endovascular coiling vs. neurosurgical clipping. BMC Neurology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 15, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news

Stent Assisted Coiling of Middle Cerebral Artery AneurysmsStent Assisted Coiling of Middle Cerebral Artery Aneurysms
Endovascular coiling of middle cerebral artery aneurysms has proved challenging. Can stent assisted embolization increase the likelihood of success? Journal of Neurointerventional Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 24, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news