Boston Scientific shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country's Therapeutic Goods Administration to issue a recall. The Promus stents were shipped with incorrect directions for use Down Under, according to a TGA release.
New Johns Hopkins research suggests that people who undergo minimally invasive placement of stents to open clogged leg arteries are significantly less likely than those who have conventional bypass surgery to need a second treatment for the condition within two years.
Ground-breaking research is harnessing the unique properties of diamonds to develop a new generation of lasers that could lead to many benefits, from better treatment of skin complaints and diabetes-related eye conditions to improved pollution monitoring and aeronautical engineering.
A new study reports that peripherally inserted central catheters (PICCs) do not reduce the risk of central line associated bloodstream infections (CLABSIs) in hospitalized patients. PICCs have become one of the most commonly used central venous catheters (CVCs) in healthcare settings since they are considered easier and safer to use, with less risk of CLABSIs.
CorMatrix Cardiovascular, a leading medical device developer, today announced the receipt of three U.S. Patents for replacement heart valves that utilize unique biomaterial called extracellular matrix (ECM). The established leader in cardiac biomaterial, CorMatrix has more than 120 U.S. and international patent applications pending on various ECM-based compositions and structures.
Some animals—like the octopus and cuttlefish—transform their shape based on environment, fending off attackers or threats in the wild. For decades, researchers have worked toward mimicking similar biological responses in non-living organisms, as it would have significant implications in the medical arena.
Medical device giant Edwards Lifesciences is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.
A Washington, D.C., cardiologist was hit with a $17 million judgment after being found guilty of submitting false claims for nuclear imaging tests to Medicare and state health programs. Federal authorities accused Dr. Ishtiaq Malik of double-billing and submitting false claims for myocardial perfusion studies or "nuclear stress tests."
Abiomed, Inc., a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 15,000 Impella® pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General Hospital in Sacramento, California with an Impella pump that provided prophylactic circulatory support.
Thubrikar’s Next-Generation TAVI system surpasses ISO requirement for durability and achieves other milestonesAugust 1, 2013 6:27 pm | News | Comments
Thubrikar Aortic Valve, a privately held medical device company developing a next-generation transcatheter aortic valve implantation (TAVI) system, announced today that its Optimum TAV has surpassed 200 million cycles in an ongoing durability test - which simulates over 5 years in humans and meets the requirement set by the International Organization for Standardization (ISO) - in a third party GLP study.
Teleflex (NYSE:TFX) won FDA clearance for expanded sizes and uses of its Arrow GPSCath Balloon Dilatation catheter, a device the company picked up during the 2012 buyout of Hotspur Technologies. The FDA win lets Teleflex sell the catheter in new 80 cm lengths and in a higher burst pressure rating.
This week, the U.S. Food and Drug Administration (FDA) announced the recall of GE Healthcare’s Nuclear Medicine Systems were recalled following an incident at a VA Medical Center in which a patient died due to injuries sustained while being scanned.
An algorithm capable of diagnosing heart rhythm with just 3 seconds’ worth of signal, and the demonstration that it is possible to come up with the diagnosis without stopping cardiac massage, constitute the types of solutions and proposals being developed by researchers in the Signal and Communications Group of the Faculty of Engineering in Bilbao.
Could harvesting stem cells for therapy one day be as simple as asking patients for a urine sample? Researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine and colleagues have identified stem cells in urine that can be directed to become multiple cell types.
Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm LengthsJuly 30, 2013 5:00 pm | News | Comments
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, received FDA 510(k) clearance to market the company’s ARROW ® GPSCath ® Balloon Dilatation Catheters in Higher Rated Burst Pressure (RBP) and 80 cm lengths.
The University of Salford has carried out a systematic review of the literature to research the effectiveness of telehealth on clinical outcomes, cost effectiveness and patient experience. Telehealth allows patients to monitor long-term health conditions from home, reducing visits to a clinic or hospital.
Advanced Catheter Therapies, Inc. (ACT) has announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8398589 B2 for its catheter technology. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.
InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), a leader in embolic protection stents, said the first patient has been enrolled in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard™ Prime Embolic Protection Stent (EPS) in patients suffering from ST Elevation Myocardial Infarction (STEMI).
Cook Medical has partnered with IU Health to evaluate a potential treatment for peripheral arterial disease (PAD), a vascular disease of the legs. The treatment involves the placement of a stent, which is a small, metal mesh tube that is inserted into the artery to treat blockages of blood flow.
A prominent hacker who discovered a way to have automatic teller machines spit out cash and was set to deliver a talk about hacking pacemakers and other wireless implantable medical devices has died in San Francisco, authorities and his employer said.
Vascular Solutions' Q2 earnings landed exactly within analyst expectations, ending the company's long streak of beating the Street. Despite driving profits up almost 20% and boosting guidance estimates to reflect healthy revenue, Wall Street responded by sending share prices down 0.7% by the end of the day.
Dr. Nick Cavros, interventional cardiologist with Cardiovascular Institute of the South (CIS) at Lafayette General Medical Center in Lafayette, Louisiana, used a new hand-held mechanical aspiration system to remove blood clots and increase blood flow.
Using gold nanoparticles, MIT researchers have devised a new way to turn blood clotting on and off. The particles, which are controlled by infrared laser light, could help doctors control blood clotting in patients undergoing surgery, or promote wound healing.
Surgeons in Europe have completed clinical trials on the world’s first serviceable bioprosthetic heart valve, paving the way for the CE mark and commercial sale of an advanced heart valve that eliminates many common problems for cardiac valve patients.
The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”