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7 medtech stories we missed this week: Sept. 22, 2017
[Image from unsplash.com]From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion si...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Diagnostics Food & Drug Administration (FDA) Laboratory Instruments/Laboratory Supplies mHealth (Mobile Health) Research & Development Vascular Bioventus LLC Contego Medical Covalon Technologies Getinge Guerbe Source Type: news

Contego Medical wins CE Mark for Vanguard IEP angioplasty system
Contego Medical said today it won CE Mark approval in the European Union for its Vanguard IEP periperhal balloon angioplasty system and launched the device in the region. The newly cleared Vanguard IEP system incorporates a peripheral angioplasty balloon and distal embolic filter on a single catheter, the Raleigh, N.C.-based company said. The system has an over-the-wire design with a sheathless integrated 150-micron pore filter distal for the angioplasty balloon. “The Vanguard IEP System is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease. This device...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Contego Medical Source Type: news

TCT 2016: The best of the rest
The annual Transcatheter Cardiovascular Therapeutics conference went down in Washington, D.C., this week, with late-breaking study results beginning Oct. 29. After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, featuring big-name devices for structural heart repair and peripheral artery disease at the Transcatheter Cardiovascular Therapies conference. Below is a roundup of miscellaneous releases from the conference: Freudenberg Medical launches new products F...
Source: Mass Device - November 3, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Catheters Clinical Trials TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news

Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Contego Medical Announces Positive Clinical Data for Paladin(R) System, the First Post-Dilation Balloon with Integrated Embolic Protection(TM) Technology
Data presented at the Leipzig Interventional Course (LINC) demonstrates breakthrough treatment for Carotid Artery Disease RALEIGH, N.C., Jan. 26, 2016 -- (Healthcare Sales & Marketing Network) -- Contego Medical, an innovator in developing next generat... Devices, InterventionalContego Medical, Paladin System, angioplasty balloon, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 26, 2016 Category: Pharmaceuticals Source Type: news

Contego Medical Announces European Commercialization of the Paladin(R) Carotid Post-Dilation Balloon with Integrated Embolic Protection(TM) Technology
Presenting at the Leipzig Interventional Course (LINC) from January 26th-29th in Leipzig, Germany. RALEIGH, N.C., Jan. 14, 2016 -- (Healthcare Sales & Marketing Network) -- Contego Medical today announced the European commercialization of the Paladin&r... Devices, Interventional, Product LaunchContego Medical, Paladin System, angioplasty balloon, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 14, 2016 Category: Pharmaceuticals Source Type: news

VIVA 2015 Roundup: Medtronic touts Valiant stent graft, PAD stent-treatment data
Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev. The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valian Captivia thoracic stent graft system for treating type B aortic dissections, reporting safety and efficacy at 2-years. Data from the 2-year follow up of the 35-patient FDA approved IDE trial reported no post-index procedure ruptures or conversions, device related adverse events or&n...
Source: Mass Device - November 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Abbott Avinger Boston Scientific C.R. Bard Cook Medical Medtronic Spectranetics Corp. TriVascular TVA Medical Vascular Dynamics Vascular Interventional Advances (VIVA) Source Type: news

Medtech approvals: FDA releases May 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 51 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 26 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 547 Total Active: 379 Total On Hold: 168 Summary of All PMA Submissions Originals: 1 Supplements: 62 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 51 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 109.5 FDA Time: 86...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

FDA Clears Neck-Access Neuroprotection for Carotid Stenting FDA Clears Neck-Access Neuroprotection for Carotid Stenting
The Enroute Transcarotid Neuroprotection System avoids groin access, using blood flow reversal to capture debris from carotid angioplasty and stenting procedures. FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 9, 2015 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA clears system to reduce stroke risk during stent and angioplasty procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 9, 2015 Category: American Health Source Type: news

Angioplasty After Carotid Stenting and StrokeAngioplasty After Carotid Stenting and Stroke
The CREST analysis showed that poststent deployment angioplasty reduced the risk of restenosis by 64% but was associated with a nearly fourfold increased risk of stroke. Heartwire (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 10, 2013 Category: Consumer Health News Tags: Cardiology News Source Type: news

Ballooning After Carotid Stenting Not Best Choice? (CME/CE)
ORLANDO (MedPage Today) -- Balloon angioplasty after deployment of a carotid stent may increase stroke risk, a retrospective analysis of the CREST trial showed. (Source: MedPage Today Meeting Coverage)
Source: MedPage Today Meeting Coverage - May 10, 2013 Category: Journals (General) Source Type: news