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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

MassDevice.com +5 | The top 5 medtech stories for September 20, 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 10 largest medical device companies in the world Mergers & acquisitions continue to change the medical device landscape, as reflected in Medical Design & Outsourcing’s new Big 100 list. We pulled financial reg...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Reva Medical ’s Fantom bioresorbable, drug-eluting vascular scaffold succeeds at 6 months
As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices. In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary bioresorbable vascular scaffold succeeded after six months. The device was designed to address challenges like strut size and expansion capacity, the researchers wrote. Get the full story at our sister site, Drug Delivery...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Wall Street Beat Abbott Reva Medical Inc. Source Type: news

Surmodics Announces Global Approvals of .014 & #226; �? Low-Profile PTA Balloon Dilation Catheter
The company received FDA 510(k) and CE Mark clearance EDEN PRAIRIE, Minn. - Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product...This story is related to the following:Catheters (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - September 19, 2017 Category: Medical Devices Source Type: news

SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath
SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months. The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction and particulates, the Eden Prairie, Minn.-based company said. SurModics said the clearance and coming launch of the low-profile PTA cath is a continuation of the company’s strategy to supply whole-product vascular solutions. ...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular SurModics Inc. Source Type: news

7 medtech stories we missed this week: Sept. 15, 2017
[Image from unsplash.com]From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to lead its Restrata wound matrix study. The study will surgery the clinical outcomes of Restrata treatments for diabetic foot ulcers and test for effectiveness and safety. Restrata is a fully synthetic wound matrix that is FDA-cleared for ...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Dental Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Surgical Acera Surgical Contego Medical Fresenius MedTech OBP Medical Pinnacle Sciences Plusoptix Telos Source Type: news

Firefighter ™ PTCA Balloon Catheter Receives Regulatory Approval in South Korea
(Source: Microport News Release)
Source: Microport News Release - September 12, 2017 Category: Medical Devices Source Type: news

Study examines use of systolic blood pressure at time of primary percutaneous coronary intervention
(Society for Cardiovascular Angiography and Interventions) Researchers have led a retrospective single-center study examining simple hemodynamic parameters obtained at the time of cardiac catheterization to predict in-hospital mortality following ST-elevation myocardial infarction (STEMI). Current 30-day mortality rates for patients with STEMI range from 2.5% to 10%, and 10.5%-24% of those patients require mechanical hemodynamic support. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 11, 2017 Category: International Medicine & Public Health Source Type: news

Japan approves Medtronic ’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The In.Pact Admiral DCB has demonstrated superior one-year clinical outcomes in Japan and across Medtronic In.Pact SFA clinical trials, providing patients with an improved restoration of blood flow and reduced need for additional revasc...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Medtronic Source Type: news

BLS Crews in Paris Detect Atypical STEMI via 12-Lead ECG
By Jonathan Gonzva, MD; Laure Alhanati, MD; Stéphane Dubourdieu, MD; Daniel Jost, MD; Hugues Lefort, MD; Benoît Frattini, MD & Jean-Pierre Tourtier, MD A 61-year-old man calls the Paris Fire Brigade dispatch center with a complaint of dental pain. He reports feeling pain in the jaw for the past 35 minutes, which he says now extends to the armpits. He also reports that he experienced the same feeling the day before. The patient's age and hyperlipidemia were his only cardiovascular risk factors with atorvastatine and budesonide as the usual treatments. The physician stationed at the dispatch cen...
Source: JEMS Patient Care - September 7, 2017 Category: Emergency Medicine Tags: International Cardiac & Resuscitation Columns Patient Care Source Type: news

Rethinking dual antiplatelet guidelines in acute coronary syndrome? (CHANGE-DAPT)
(European Society of Cardiology) New research presented at ESC Congress today1 suggests that for acute coronary syndrome (ACS) patients who require percutaneous coronary intervention (PCI), treatment according to contemporary guidelines for dual anti-platelet therapy (DAPT) could be less preferable than sticking to older guidelines. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 29, 2017 Category: International Medicine & Public Health Source Type: news

LSUHealthNO research award to improve heart attack recovery
(Louisiana State University Health Sciences Center) LSU Health New Orleans will receive $735,000 over two years to study the effectiveness of the first patented drug-eluting guidewire in preventing a complication that can occur following treatment of heart attacks with angioplasty. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - August 28, 2017 Category: Biology Source Type: news

Ra Medical CEO Irwin aims for Feb 2018 IPO
In May, Ra Medical received a nod from the FDA for its Dabra arteriosclerosis laser, clearing it for use in the US. It was a decision the company had been waiting on for approximately 3 years, CEO Dean Irwin told MassDevice.com in an interview, and signaled a significant shift forward. “In 2014, we submitted to the FDA, and here in 2017, just on May 24th, we received the go ahead to begin marketing in the United States,” Irwin said. Ra Medical won CE Mark approval in the European Union last October, giving the company time to launch in the region, which it’s been operating in for several mo...
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Regulatory/Compliance Ra Medical Source Type: news

Firefighter ™ PTCA Balloon Catheter Gains Regulatory Approval in Argentina
(Source: Microport News Release)
Source: Microport News Release - August 17, 2017 Category: Medical Devices Source Type: news

Angioplasty Outcomes Almost Equal Among Hospitals
Title: Angioplasty Outcomes Almost Equal Among HospitalsCategory: Health NewsCreated: 8/7/2017 12:00:00 AMLast Editorial Review: 8/8/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - August 8, 2017 Category: Cardiology Source Type: news

Angioplasty outcomes almost equal among hospitals
Patients who undergo percutaneous coronary intervention have similar outcomes at different hospitals, researchers said. (Source: Health News - UPI.com)
Source: Health News - UPI.com - August 8, 2017 Category: Consumer Health News Source Type: news

Angioplasty Outcomes Almost Equal Among Hospitals
'Safety-net' facilities do as well as other hospitals with the artery procedure, researchers find (Source: WebMD Health)
Source: WebMD Health - August 7, 2017 Category: Consumer Health News Source Type: news

Angioplasty Outcomes Almost Equal Among Hospitals
'Safety-net' facilities do as well as other hospitals with the artery procedure, researchers find Source: HealthDay Related MedlinePlus Pages: Angioplasty, Health Disparities, Health Facilities (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - August 7, 2017 Category: Consumer Health News Source Type: news

Angioplasty Outcomes Almost Equal Among Hospitals
MONDAY, Aug. 7, 2017 -- Patients who have an artery-opening procedure called percutaneous coronary intervention (PCI) have similar outcomes whether they're treated at so-called safety-net or non-safety-net hospitals, researchers say. Safety-net... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 7, 2017 Category: General Medicine Source Type: news

U.S. Hospitals Set Record for Fast Heart Attack Care
There's never been a better time to be treated for a heart attack. U.S. hospitals have set a record for how quickly they open blocked arteries, averaging under one hour for the first time since these results have been tracked. More than 93 percent of patients now have their arteries opened within the recommended 90 minutes of arrival. "Things have definitely improved" from a decade ago, when less than half of heart attack patients were treated that fast, said Dr. Fred Masoudi, a University of Colorado cardiologist who led a recent report examining response times. It's based on records from about 85 percent of U.S...
Source: JEMS Patient Care - July 31, 2017 Category: Emergency Medicine Authors: Marilynn Marchione, Chief Medical Writer, Associated Press Tags: Patient Care Cardiac & Resuscitation News Source Type: news

U.S. Hospitals Set Record for Fast Heart Attack Care
There's never been a better time to be treated for a heart attack. U.S. hospitals have set a record for how quickly they open blocked arteries, averaging under one hour for the first time since these results have been tracked. More than 93 percent of patients now have their arteries opened within the recommended 90 minutes of arrival. "Things have definitely improved" from a decade ago, when less than half of heart attack patients were treated that fast, said Dr. Fred Masoudi, a University of Colorado cardiologist who led a recent report examining response times. It's based on records from about 85 percent of U.S...
Source: JEMS: Journal of Emergency Medical Services News - July 31, 2017 Category: Emergency Medicine Authors: Marilynn Marchione, Chief Medical Writer, Associated Press Tags: Patient Care Cardiac & Resuscitation News Source Type: news

Medtronic's Evolut PRO Now Available in Europe
Medtronic has announced that its latest transcatheter aortic valve, the CoreValve Evolut PRO, has received the CE mark and is now available for use in Europe. In a reversal of the usual order of device approvals, FDA approval pre-dated the CE Mark - the Evolut PRO was first given an FDA okay back in March. This new generation valve utilizes a biocompatible porcine outer wrap that increases surface contact and sealing to reduce paravavular leaks (PVL). Another major improvement over earlier iterations was the reduced necessity for permanent pacemaker implantation: only 10% in this cohort. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 31, 2017 Category: Cardiology Source Type: news

Clinical Trial to Study If 3-Months of DAPT is Safe After XIENCE Stent
The study, called XIENCE Short DAPT, will evaluate if 3 months of DAPT is non-inferior to the current standard of 12 months after implantation with a XIENCE stent for patients who are at high risk of bleeding. The study will enroll approximately 2,000 patients at 100 sites in the U.S. and Asia. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 26, 2017 Category: Cardiology Source Type: news

Blacks and Whites Have Similar Outcomes After PCI Blacks and Whites Have Similar Outcomes After PCI
A study designed to look for differing outcomes when black and white U.S. veterans undergo percutaneous coronary intervention (PCI) instead found no differences once confounding factors were taken into account.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - July 25, 2017 Category: Intensive Care Tags: Family Medicine/Primary Care News Source Type: news

Roxwood Medical Announces Agreement with Abbott for Distribution of Products in U.S.
REDWOOD CITY, Calif., July 25, 2017 -- (Healthcare Sales & Marketing Network) -- Roxwood Medical Inc., a leading provider of advanced cardiovascular specialty catheters, today announced it has entered into an exclusive agreement with Abbott for distributi... Devices, Interventional, Cardiology, Distribution Roxwood Medical, Abbott, CenterCross, Percutaneous coronary intervention (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 25, 2017 Category: Pharmaceuticals Source Type: news

Firefighter ™ PTCA Balloon Catheter Gains CFDA Approval
(Source: Microport News Release)
Source: Microport News Release - July 24, 2017 Category: Medical Devices Source Type: news

Bayer ’s Xarelto in Combination with Single Antiplatelet Therapy Receives Positive CHMP Opinion for Treatment of Patients with Atrial Fibrillation requiring oral Anticoagulation and undergoing Percutaneous Coronary Intervention with Stent Placement (for specialized target groups only)
Positive CHMP Opinion is based on data from the Phase IIIb PIONEER AF-PCI study, which demonstrated significantly reduced rates of clinically significant bleeding with Xarelto compared with VKA in patients with non-valvular atrial fibrillation (AF) who require oral anticoagulation and are also receiving antiplatelet therapy after percutaneous coronary intervention (PCI) with stent placement (1) / PIONEER AF-PCI is the first and currently only randomised clinical trial of a non-vitamin K antagonist oral anticoagulant (NOAC) in this patient population / Final decision of European Commission expected by the end of this year (...
Source: Bayer Company News - July 21, 2017 Category: Pharmaceuticals Source Type: news

Intact Vascular launches Toba II BTK trial in EU
Intact Vascular today announced the European launch of the Toba II BTK clinical trial of its Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for treating critical limb ischemia. The 1st European patient in the trial was enrolled by Dr. Marianne Brodmann and Dr. Peter Reif at Austria’s Medical University Graz, the Wayne, Penn.-based company said. “We are pleased to be the 1st center in Europe to commence enrollment in Toba II BTK. I believe the Tack endovascular system is a very promising technology designed to optimize dissection repair while l...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Intact Vascular Source Type: news

Heart vessel-clearing procedure can benefit some at age 90 and older
People in their nineties and older represent a tiny but growing fraction of patients who undergo a procedure called percutaneous coronary intervention (PCI) to clear blocked blood vessels in the heart, new research shows. (Source: Reuters: Health)
Source: Reuters: Health - July 12, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Gives Approval to Medtronic's CoreValve for Use in Patients at Intermediate Risk for Surgical Valve Replacement
Based on results from the landmark SURTAVI Clinical Trial, presented at the American College of Cardiology Annual Meeting in March, and published in the New England Journal of Medicine, the FDA has approved the CoreValve TAVR self-expanding platform for use in patients with severe and symptomatic aortic stenosis who are at "intermediate" risk for surgical valve replacement, defined as mortality>= 3% at 30 days. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 10, 2017 Category: Cardiology Source Type: news

FDA OKs Intact Vascular IDE app for 6-month endpoint in BTK Tack angioplasty trial
Intact Vascular said today that the FDA approved an investigational device exemption supplemental application to modify the primary endpoint in a below-the-knee clinical trial of its Tack optimized balloon angioplasty from 12 months to 6 months. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, the Wayne, Penn.-based company said. The Toba II BTK study is a prospective, multi-center, single-arm study which looks to investigate the saf...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Vascular Intact Vascular Source Type: news

Firefighter ™ PTCA Balloon Dilatation Catheter Gains Regulatory Approval in Brazil
(Source: Microport News Release)
Source: Microport News Release - July 7, 2017 Category: Medical Devices Source Type: news

Barriers to Achieving Optimal Door-to-Balloon Time in Japan: Interview with Dr. Shun Kohsaka
In this interview, co-author Dr.Shun Kohsaka of the Department of Cardiology at Keio University School of Medicine in Tokyo, Japan, discusses a study, recently published in the Japanese Circulation Society's Circulation Journal, demonstrating that door-ro-balloon time in half of STEMI cases in Japan is greater than 90 minutes.(Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 30, 2017 Category: Cardiology Source Type: news

Bard wins FDA approval for LifeStream covered iliac stent
C.R. Bard (NYSE:BCR) said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said. “C. R. Bard is proud to build upon its vast history and experience in angioplasty balloons, stents and covered stents to offer physicians this new option,” chairman & CEO Timothy Ring said in prepared remarks. “The LifeStream covered stent expands t...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stents Wall Street Beat C.R. Bard Peripheral Artery Disease Source Type: news

Prognostic Impact of Revascularization in Poor-Risk Patients with Critical Limb Ischemia: Interview with Dr. Osamu Iida
Dr. Iida was principal investigator for the PRIORITY registry, testing whether revascularization impacted survival at one-year for poor-risk-CLI patients. The study was published in the June 12 issue of JACC: Cardiovascular Interventions and looked at over 600 patients in 37 hospitals across Japan. (Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 18, 2017 Category: Cardiology Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 15, 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. Johnson & Johnson Innovation backs 3D printing, coatings and contact lenses Johnson & Johnson Innovation, the incubation arm of healthcare giant Johnson & Johnson, said today that it’s investing in a variety o...
Source: Mass Device - June 15, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

China ’ s Venus Medtech snaps up TAVR device developer InterValve
Chinese heart valve maker Venus Medtech said today it acquired U.S.-based transcatheter aortic valve replacement device developer InterValve for an undisclosed amount. Intervalve produces the V8 and TAV8 aortic valvuloplasty balloon catheters designed for performing percutaneous balloon angioplasty procedures and for pre and post-dilation during TAVR procedures. Venus said that the shape of the balloon helps protect the valve annulus structure and minimize expansion of the valve. Both the V8 and TAV8 balloons have FDA approval and CE Mark approval in the European Union, Venus Medtech said. “The balloon of Interv...
Source: Mass Device - June 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters Mergers & Acquisitions InterValve Inc. Venus Medtech Source Type: news

Prolonged DAPT After PCI: Risk Score Helps Identify Those Most Likely to Be Harmed (FREE)
By Amy Orciari Herman Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD The DAPT (dual antiplatelet therapy) score helps identify patients for whom prolonged treatment after percutaneous coronary intervention would be harmful, suggests an analysis in the Annals of Internal Medicine. Researchers retrospectively applied … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - June 13, 2017 Category: Primary Care Source Type: news

No difference in rate of adverse cardiovascular events when comparing anticoagulants
In patients undergoing transradial primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI), there was no significant difference in the rate of a composite of death, myocardial infarction and stroke whether they were anticoagulated with bivalirudin or unfractioned heparin, according to a study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 17, 2017 Category: Science Source Type: news

Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These procedures can cause target lesion revascularization, requiring the need for repeat treatments. Alucent Medical’s photo-activated drug therapy, NVS, is designed to build natural scaffolding and keep the vessel open, according to the S...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular alucentmedical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 16, 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. Corindus touts high success rate in CorPath 200 PCI registry study Corindus Vascular Robotics today released post-market findings from the Precision registry study of its CorPath 200 system used during percutaneous coronary int...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Philips showcases new integrated image-guided therapy solutions at 2017 EuroPCR to transform cardiac care and help improve patient care
Highlights Philips Azurion, the next generation image guided therapy platform to optimize system integration and lab performance Launches unique portfolio of iFR co-registration technologies, including iFR Roadmap and SyncVision, to enhance stenting str... Devices, Interventional, Cardiology, Radiology Royal Philips, angioplasty, iFR Roadmap, SyncVision iFR (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 16, 2017 Category: Pharmaceuticals Source Type: news

Abbott recalls heart catheters on balloon sheath issue
Abbott (NYSE:ABT) is recalling some 450,000 coronary catheters on the risk that removing a protective balloon sheath can damage the ballon during angioplasty procedures. In a March 22 letter to customers, Abbot said the recall affects its NC Trek RX and NC Traveler RX coronary dilatation catheters and the NC Tenku RX PTCA balloon catheter. “Product from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon,” Abbott said. “If excessive force is required to remove the balloon sheath, the sheath m...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Food & Drug Administration (FDA) Recalls Regulatory/Compliance Abbott Source Type: news

Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters
Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 15, 2017 Category: Food Science Source Type: news

Adventitial Steroid After PAD Angioplasty Blunts CRP Rise: DANCE Adventitial Steroid After PAD Angioplasty Blunts CRP Rise: DANCE
Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 15, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Large multicenter study shows high success rate for robotic PCI procedures
Results from the PRECISION trial (Efficacy and Safety Outcomes of Radial- vs Femoral-Access Robotic Percutaneous Coronary Intervention: Final Results of the Multicenter PRECISION Registry) were presented today as a late-breaking clinical trial. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 12, 2017 Category: Science Source Type: news

Blood Vessel-Clearing Procedure Riskier on Weekends: Study
Though low overall, the odds of dying are doubled if angioplasty is done on Saturday or Sunday Source: HealthDay Related MedlinePlus Pages: Angioplasty, Health Facilities, Patient Safety (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 12, 2017 Category: Consumer Health News Source Type: news

Blood Vessel-Clearing Procedure Riskier on Weekends: Study
THURSDAY, May 11, 2017 -- Although you often don't have a choice of when you get the heart procedure called percutaneous coronary intervention (PCI), new research suggests that having it done over the weekend may be more risky. The study reported... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - May 11, 2017 Category: General Medicine Source Type: news

Abiomed dips on missed Q4 earnings, despite sales beat
Share prices for Abiomed (NSDQ:ABMD) dipped today after the company reported fiscal 4th-quarter earnings that missed expectations, despite a top-line gain of nearly 33%. The Danvers, Mass.-based heart pump maker posted profits of $14.9 million, or 33¢ per share, on sales of $124.7 million for the 3 months ended March 31, for a bottom-line increase of 35.5% on sales growth of 32.7% compared with Q4 2016. But analysts on Wall Street were looking for earnings per share of 35¢; Abiomed topped the consensus Street estimate for sales by more than $2 million. Full-year profits were $52.1 million, or $1.17 per share...
Source: Mass Device - May 4, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices MassDevice Earnings Roundup Wall Street Beat Abiomed Source Type: news

India ’ s NPPA to audit hospitals on claims of stent overcharging
India’s National Pharmaceutical Pricing Authority is initiating an audit of all angioplasty cases at several hospitals and medical institutions in the country after receiving complaints of overcharging for stents, according to an Indian Express report. The NPPA’s audit will focus on hospitals that have “inconclusively” responded to the organization, according to the report. “Hospitals have replied in only half the cases. Audit will be done for all angioplasty cases done during the period — in some cases by the state drug controllers and in others directly by NPPA,” NPPA chair Bhupe...
Source: Mass Device - May 1, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Stents Indian National Pharmaceutical Pricing Authority (NPPA) Source Type: news