Implantables
Thoracic Endografts Used Successfully to Remove Tumors Invading the Aorta
May 8, 2013 10:43 am | by American Association for Thoracic Surgery | News | CommentsSome chest tumors may invade one of the great vessels of the body, the aorta. Surgical removal of these tumors is very challenging and necessitates the support of a heart-lung machine. Therefore, there is an increased risk of complication and death. In a small series of patients, placing a stent within the aorta facilitated the subsequent removal of tumor and eliminated the need for heart-lung bypass.
Elixir Medical Announces FDA Approval to Commence EXCELLA III Clinical Trial with DESyne® Nx Novolimus Eluting Coronary Stent System in the United States
May 8, 2013 7:00 am | by The Associated Press | News | CommentsSUNNYVALE, Calif--(BUSINESS WIRE)--May 8, 2013--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it has received approval from the Food and Drug Administration (FDA) to initiate patient enrollment...
Mitek Sports Medicine Launches Small Diameter Dual-Thread Suture Anchor and New PTRC Repair System
May 7, 2013 11:29 am | by Mitek Sports Medicine | News | CommentsMitek Sports Medicine, a leading orthopaedics sports medicine company, announced the launch of the HEALIX 3.4-mm Suture Anchor, the company's smallest dual-thread suture anchor for rotator cuff repair, and the launch of a new double-loaded minimally invasive partial thickness rotator cuff repair system, as part of its HEALIX TRANSTEND Implant System.
GHX Delivers Industry’s First Implantable Devices Supply Chain Solutions for Healthcare
May 7, 2013 11:09 am | by GHX | News | CommentsGHX has announced Case Xpert and Order Intelligence, the healthcare industry’s first end-to-end supply chain solutions for managing and tracking implantable medical devices, including the physician preference items (PPI) used in operating rooms.
FDA Approves BIOTRONIK’s Ilesto 7 ICD/CRT-D Series
May 7, 2013 10:02 am | by The Associated Press | News | CommentsLAKE OSWEGO, Ore.--(BUSINESS WIRE)--May 7, 2013--BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced that the Food and Drug Administration (FDA) granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator...
Enrollment Completed for Low-Risk Aortic and Mitral Patient Groups For On-X® Prosthetic Heart Valve Anticoagulation Clinical Study
May 7, 2013 9:00 am | by The Associated Press | News | CommentsMINNEAPOLIS--(BUSINESS WIRE)--May 7, 2013--On-X ® Life Technologies, Inc. (On-X LTI) announced today that enrollment for the Low-Risk Aortic Valve and Mitral Valve Patient Groups has been completed. The Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) was initiated with US FDA...
Medtronic Announces FDA Approval of New Portfolio Of Next-Gen Cardiac Resynchronization Therapy Devices, Implantable Cardioverter-Defibrillators
May 6, 2013 10:18 am | by Medtronic | News | CommentsMedtronic, Inc. has announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of its newest cardiac devices: the Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).
St. Jude Medical Enrolls First Patient in Next-Generation Quadra Study
May 3, 2013 9:46 am | by Business Wire | News | CommentsSt. Jude Medical, a global medical device company, today announced first enrollment of its MultiPoint Pacing clinical study to build upon its first- to-market Quadripolar Pacing System. Patients will be implanted with the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) and Quartet lead to assess pacing in multiple locations in the heart.
Make Two Models and Call Me in the Morning
May 2, 2013 2:47 pm | by Joe Hiemenz, Technical Communications Manager, Stratasys Inc. | Stratasys Inc. | Articles | CommentsA prototype lab is tasked with inventing solutions to design challenges presented to them by surgeons with medical device ideas. Utilizing a fused-deposition modeling machine and design software, engineers are able to create physical prototypes of medical devices that are able to be put through functional testing.
MD&M East 2013
April 30, 2013 4:30 pm | by MDT Staff | EventsThe newly reformatted MD&M East four day conference running alongside the tradeshow, covers everything you need to know from concept development to supplier management, giving you the essential updates to successfully management every step in the product development efficiently and cost effectively.
2-Year-Old Girl Gets Windpipe Made from Stem Cells
April 30, 2013 2:04 pm | by Lindsey Tanner, AP Medical Writer | News | CommentsA 2-year-old girl born without a windpipe now has a new one grown from her own stem cells, the youngest patient in the world to benefit from the experimental treatment. Hannah Warren has been unable to breathe, eat, drink or swallow on her own since she was born in South Korea in 2010.
InBreath Scaffold and Bioreactor Used in First U.S. Transplant of a Regenerated Trachea
April 30, 2013 12:12 pm | by Globe Newswire | News | CommentsHarvard Bioscience has announced that the InBreath tracheal scaffold and bioreactor system manufactured by Harvard Apparatus Regenerative Technology, Inc. (HART), its wholly owned regenerative medicine technology subsidiary, were used in the first successful transplant of a regenerated trachea in the United States.
Medtronic Reports Initial Implants of Novel Stent Graft for Aortic Aneurysms Involving Branch Vessel
April 29, 2013 4:32 pm | News | CommentsVascular specialists at Carolinas HealthCare System in Charlotte, N.C., and the Cleveland Clinic in Ohio recently performed the initial implants of a novel stent graft system from Medtronic as part of a U.S. Food and Drug Administration initiative designed to encourage more early-stage clinical research on new medical devices in the United States.
Photo of the Day: Surgeries by Age Group
April 29, 2013 3:54 pm | by CompHealth | News | CommentsGoing Under the Knife—Millions of Americans will have surgery this year. Whether it’s the result of an emergency, an exploratory procedure, or even elective, some surgical procedures are more common depending on your age. An infographic by the team at Top Surgeries Graphic - CompHealth.
Sorin Group Receives Conditional FDA Approval to Conduct IDE Clinical Trial for Perceval (TM) S Sutureless Aortic Valve in the United States
April 29, 2013 10:00 am | by The Associated Press | News | CommentsMILAN, Italy--(BUSINESS WIRE)--Apr 29, 2013--Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today it has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption...
athenahealth Hosts Health Care Hack-a-Thon
April 29, 2013 8:45 am | by GlobeNewswire | News | Commentsathenahealth, Inc., a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, in partnership with MIT's H@cking Medicine, invites the health care, technology and scientific communities to participate in a Hack-a-Thon on May 4 and 5 at athenahealth's headquarters in Watertown, Mass.
Spine Wave Announces U.S. FDA's 510K Clearance of the StaXx(R) IB System, an Intervertebral Body Fusion Device
April 29, 2013 8:00 am | by The Associated Press | News | CommentsSpine Wave, Inc. a privately held medical device company committed to the development and delivery of high-quality innovative medical devices for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration to...
April 2013 Digital Edition
April 25, 2013 2:45 pm | by MDT Staff | Digital Editions | CommentsGiven the number of device applications that involve the transfer of a gas or liquid, it is no wonder pump technology is such a significant part of many healthcare-related products. “Innovation Drives Pump Technology to Meet Today’s Medical Designs” focuses on how today’s medical device demands are being answered by advanced pump technology.
Implant Brings High Hopes for Back Pain Relief
April 25, 2013 9:35 am | by ReutersTV | Videos | CommentsA new spinal implant developed in Israel, has radically improved the life of at least one patient who, four years ago, believed he would spend his twilight years in constant pain. Seventy-nine-year-old Moshav farmer Yehuda Schwartz suffered from a debilitating back condition common among senior citizens but says, since receiving the implant, he's been given a new lease on life.
Under the Skin, a Tiny Laboratory
April 24, 2013 9:55 pm | by I-Micronews | News | CommentsHumans are veritable chemical factories - we manufacture thousands of substances and transport them, via our blood, throughout our bodies. Some of these substances can be used as indicators of our health status. A team of EPFL scientists has developed a tiny device that can analyze the concentration of these substances in the blood.
Eastman Expands Non-Phthalate Plasticizer Portfolio
April 24, 2013 5:10 pm | by Eastman Chemical Company | News | CommentsEastman Chemical Company has announced it will expand its non-phthalate plasticizer portfolio with the addition of Eastman 168™ SG (sensitive grade) non-phthalate plasticizer. Eastman 168 SG non-phthalate plasticizer is an enhanced grade of the Eastman 168 non-phthalate plasticizer.
Nano Compartments May Aid Drug Delivery, Catalyst Design
April 23, 2013 9:22 am | by Bill Steele, Cornell University | News | CommentsSpongelike nanoparticles whose pores can be filled with drugs offer the promise of drug delivery to specific targets in the body, avoiding unpleasant side effects. Cornell researchers have now created nanoparticles with separate compartments that could carry two or more different drugs to the same location, with precise control over the amounts.
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.
