Cardiovascular
Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent
April 24, 2013 4:40 pm | by The Associated Press | News | CommentsBased on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent.
Vascular Solutions can't dodge illegal marketing lawsuit
April 24, 2013 3:11 pm | by Mass Device | News | CommentsMinnesota medical device maker Vascular Solutions (NSDQ:VASC) wasn't able to dodge a federal off-label marketing lawsuit over its Vari-Lase varicose vein treatment devices, the company revealed in its latest financial report. A Texas court ruled last month against Vascular Solutions' motion to dismiss a U.S. Attorney's Office complaint...
Is a Hacked Pacemaker Capable of Mass Murder?
April 24, 2013 10:23 am | by Kasey Panetta, Managing Editor, ECN | Blogs | CommentsWhen you are a patient in a hospital, you tend to expect that the electronics are either top of the line or at least functioning correctly. You expect that the devices doctors implant in your body are reliable and safe. These seem like safe assumptions. Unfortunately, you could be mistaken.
Millstone Medical Outsourcing Expands Medical Device Distribution Services
April 23, 2013 6:05 pm | by PR Newswire | News | CommentsMillstone Medical Outsourcing announced today that the company will offer customers an expanded medical device distribution service, which includes the ability to distribute directly to patients and to provide wholesale distribution to distributors, hospitals, and sales representatives.
Stanford Researchers Develop New Method to Assess Options for Heart-Disease Surgery
April 23, 2013 10:36 am | by Stanford University Medical Center | News | CommentsResearchers at the Stanford University School of Medicine have developed a method of predicting which patients with heart disease would benefit more from surgery and which would benefit more from angioplasty. Drawing on Medicare records of more than 100,000 patients with heart disease, the team demonstrated that the effectiveness of coronary bypass surgery varied widely based on each individual's characteristics.
Drug Reduces Fat by Blocking Blood Vessels
April 23, 2013 10:20 am | by American Physiological Society | News | CommentsResearchers have long known that cancerous tumors grow collections of abnormal blood cells, the fuel that feeds this disease and keeps it growing. Now, new evidence in an animal model suggests that blood vessels in the fat tissue of obese individuals could provide the same purpose—and could provide the key to a new way for people to lose weight.
3v07 Medical Advertising Introduces Social Anthropology Product
April 23, 2013 9:17 am | by The Associated Press | News | CommentsLAGUNA BEACH, Calif.--(BUSINESS WIRE)--Apr 23, 2013--Healthcare advertising is seeing more medical device companies going direct to consumers thanks to the effectiveness of the Internet in reaching people looking for answers online to their medical conditions. This has made it important for...
InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
April 23, 2013 8:43 am | by The Associated Press | News | CommentsInspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuardT Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food...
Meeting the FDA’s Mandates for Unique Device Identification
April 22, 2013 2:22 pm | by Hiroshi Ono, Group Product Manager, Roland DGA Corp. | Roland DGA Corporation | Articles | CommentsThe FDA’s UDI rule is on its way and will impact virtually everyone in the industry in one way or another. While the rule has its benefits, getting to compliance will not be achieved overnight. This article provides an overview of the direct part marking technologies required to comply with the UDI rule and offers a solution that addresses the shortcomings of several other technologies.
PDL BioPharma Completes Structured Financing and Royalty Transaction with Avinger
April 22, 2013 12:50 pm | by PR Newswire | News | CommentsINCLINE VILLAGE, Nev., April 22, 2013 /PRNewswire/ -- PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) and Avinger, Inc. announced today that they closed a structured financing and royalty transaction on April 18, 2013, in which PDL will provide Avinger with up to $40 million of...
Electrophysiology Devices Market Worth US$4.4 billion by 2015
April 22, 2013 12:36 pm | by PR Newswire | News | CommentsDALLAS, April 22, 2013 /PRNewswire-iReach/ -- "Global Electrophysiology (EP) Devices- Market Growth Analysis, 2009-2015" and "Electrophysiology (EP) Devices – Emerging Markets (Brazil, Russia, India, China, South Africa And South Korea), 2009-2015" are new reports available at RnR...
TriReme Receives Shonin Approval to Market Glider™ PTCA Catheter
April 22, 2013 9:01 am | by PR Newswire | News | CommentsPLEASANTON Calif. and SINGAPORE, April 22, 2013 /PRNewswire/ -- TriReme Medical, Inc. and its affiliates (TriReme) announced today that its Japanese partner, Century Medical, Inc. (CMI), has received Shonin approval for the Glider™ PTCA catheter indicated for treating the...
Healthcare's First Direct Contracting Market Launches Today; Will Offer Mutually Beneficial Approach for Hospitals and Suppliers
April 22, 2013 9:00 am | by PR Newswire | News | CommentsIRVING, Texas, April 22, 2013 /PRNewswire/ -- Today aptitude announced the launch of the healthcare industry's first online direct contracting market, a one-stop destination designed to complement a hospital's existing contracting model or provide an alternative for those looking...
ARCA biopharma and Medtronic to Collaborate on Atrial Fibrillation Clinical Trial for Gencaro
April 22, 2013 8:00 am | by The Associated Press | News | CommentsBROOMFIELD, Colo.--(BUSINESS WIRE)--Apr 22, 2013--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc. (NYSE:MDT), a leader in medical...
ZOLL and Reflectance Medical Form Development Agreement to Incorporate Mobile CareGuide Sensor into ZOLL Monitor/Defibrillators
April 18, 2013 10:18 am | by The Associated Press | News | CommentsCHELMSFORD, Mass.--(BUSINESS WIRE)--Apr 18, 2013--ZOLL Medical Corporation, a manufacturer of resuscitation devices and related software solutions, announced today that it has entered into an agreement with Reflectance Medical, Inc. of Westborough, Mass., to develop and market a ruggedized...
Hand-Held Device Provides Lab-Quality Troponin Test Results in 15 Minutes to Identify Patients Suspected of Heart Attack
April 18, 2013 8:31 am | by The Associated Press | News | CommentsSilicon BioDevices, based in Berkeley, Calif., today presented the results of a pivotal benchmark study of its digital handheld device for high-sensitivity measurement of cardiac troponin-I, a protein found in the heart muscle used to identify heart tissue damage in patients suspected of having a heart attack.
Vasomedical Introduces Policy Makers Focusing on Healthcare Reform to EECP@ Therapy
April 16, 2013 8:30 am | by The Associated Press | News | CommentsCurrently, the United States spends more on healthcare services than any other country, exceeding $2.6 trillion, or about 18 percent of gross domestic product, annually. Most years, medical spending rises faster than inflation and the economy as a whole, which makes this a top priority for...
American College of Cardiology Journal Publishes Outcomes of Diabetes Patients Treated with Medtronic's Resolute Stent
April 15, 2013 9:06 am | by The Associated Press | News | CommentsThe current issue of JACC: Cardiovascular Interventions, a peer-reviewed journal published by the American College of Cardiology, includes an article that describes how the Resolute Integrity drug-eluting stent from Medtronic became the first and only device of its kind to be approved by the FDA with a specific indication for treating the coronary artery disease of patients with diabetes mellitus.
Randomized Controlled Multi-Center Trial Demonstrates Reduced Treatment Time and Drug Dose with EKOS vs. Catheter-Directed Thrombolysis in Peripheral Arterial Occlusions
April 15, 2013 9:00 am | by The Associated Press | News | CommentsBOTHELL, Wash.--(BUSINESS WIRE)--Apr 15, 2013--EKOS Corporation, a privately held medical device company located in Bothell, Washington, announced the results of DUET, the world’s first and only multi-center randomized trial that compares ultrasound-accelerated, catheter-directed thrombolysis...
Stenting Blocked Bowel Arteries Saves Lives
April 14, 2013 10:00 am | by PR Newswire | News | CommentsStenting reopens completely blocked bowel arteries, preventing damage and even death from a condition that causes individuals severe pain and leads to excessive weight loss, notes research being presented at the Society of Interventional Radiology's 38th Annual Scientific Meeting in New Orleans, La.
St. Jude-backed iRhythm Technologies raises another $16M for Zio wearable heart monitor
April 12, 2013 10:48 am | by Mass Device | News | CommentsiRhythm Technologies said it closed a $16 million Series D round for its Zio wearable heart monitor, saying it plans to use the proceeds to further its commercial footprint and research & development efforts. Led by Norwest Venture Partners, which added partner Casper de Clercq to iRhythm's board, the latest financing including contributions from existing backers...
Franciscan St. Francis Health Is First Hospital in Nation to Implant Breakthrough Aortic Heart Valve Device
April 11, 2013 2:30 pm | by PR Newswire | News | CommentsINDIANAPOLIS, April 11, 2013 /PRNewswire-USNewswire/ -- Franciscan St. Francis Health is the first hospital in the United States to implant a new device that could improve the quality of life for patients with aortic valve disease. The On-X® Aortic Prosthetic Valve with...
Medtronic’s Endurant ‘AAA’ Stent Graft Shows Sustained Durability in Complex Patients
April 11, 2013 11:21 am | by Medtronic | News | CommentsPresented to endovascular specialists at the 35th Charing Cross International Symposium in London, a new analysis of clinical data on the Endurant AAA Stent Graft System from Medtronic demonstrates the implanted medical device’s consistent and compelling performance in treating abdominal aortic aneurysms across a range of patient anatomies.
U-M Researchers Find New Way to Clear Cholesterol from the Blood
April 11, 2013 10:59 am | by University of Michigan | News | CommentsResearchers at the University of Michigan have identified a new potential therapeutic target for lowering cholesterol that could be an alternative or complementary therapy to statins. Scientists in the lab of David Ginsburg at the Life Sciences Institute inhibited the action of a gene responsible for transporting a protein that interferes with the ability of the liver to remove cholesterol from the blood in mice.
Global Clinical Study Initiated to Determine Safety and Effectiveness of Stent for Patients with Iliofemoral Venous Obstruction
April 11, 2013 9:00 am | by The Associated Press | News | CommentsBLOOMINGTON, Ind.--(BUSINESS WIRE)--Apr 11, 2013--Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver ® Vena™ Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. This disease is...
