The FDA has completed its evaluation of a report of a patient who died after the first dose of a multiple sclerosis drug, fingolimod (Gilenya, Novartis), and determined that it is now contraindicated in patients with certain pre-existing or recent (within the last six months) heart conditions or stroke, or who are taking certain anti-arrhythmic medications.
Boston Scientific has gained CE Mark for its Innova self-expanding bare-metal stent system, which is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery and proximal popliteal artery.
BOSTON—Implantation of the Watchman device (Boston Scientific) without a warfarin transition is safe and effective in atrial fibrillation (AF) patients with contraindications to even short-term oral anticoagulation, according to an analysis of the ASA Plavix registry, presented May 11 as a late-breaking clinical trial at the 33rd annual scientific sessions of the Heart Rhythm Society.
BOSTON—Results from the ARISTOTLE study showed that apixaban may give warfarin a run for its money, particularly for atrial fibrillation (AF); however, does the drug’s benefits differ between the varying types of AF? A secondary analysis of the ARISTOTLE trial, presented May 11 at a late-breaking clinical trial session at the 33rd annual scientific sessions of the Heart Rhythm Society, showed apixaban to take the cake in all subsets of AF patients when compared with warfarin.
LAS VEGAS—When treating a real-world sample of patients for intermittent claudication or critical limb ischemia, two off-label iliac artery stents showed a statistically significant performance goal for low major adverse event rates, according to the late breaking MOBILITY trial results presented May 10 at the 35th annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI). During the press conference, experts suggested that this study may further reinforce the role of percutaneous treatments over the more invasive surgical option for these sick patients.
The FDA issued an alert May 10, warning healthcare professionals and patients about injuries and death associated with the use of balloon angioplasty or stenting, an experimental treatment for treating chronic cerebrospinal venous insufficiency (CCSVI).
BOSTON—While previous trials have shown that women see greater benefits from cardiac resynchronization therapy (CRT) compared with men, better efforts are needed to explain why, said Aysha Arshad, MD, of the Valley Hospital in Ridgewood, N.J., and New York City, during a presentation May 9 at the 33rd annual scientific sessions of the Heart Rhythm Society. Additionally, she said that women are underrepresented in trial enrollments, which should be rectified.
The FDA has issued a draft guidance outlining its current thinking regarding information that should be included in premarket notifications for x-ray imaging devices with indications for use in pediatric populations.
The FDA has approved Boston Scientific’s Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers. The company simultaneously launched the devices in the U.S.
Starting May 30, the FDA will keep a more watchful eye on disqualified clinical investigators. Now, a clinical site investigator deemed ineligible to receive a certain test article (drugs, devices or new animal drugs) will also be ineligible to conduct any clinical investigations that would support an application for research or marketing permit for other products that are FDA regulated.
The Global Harmonization Task Force has come out with a new document that, it hopes, will help standardize the way the world’s top healthcare regulation authorities, including the FDA, handle nonconformities during audits of medical device manufacturers’ quality management systems (QMS).
Bracco Imaging has entered into a definitive agreement to acquire local subsidiaries in Argentina, Brazil and Mexico of Justesa Imagen, a distributor of contrast media in Latin America.
There may be a new player soon in the implantable device market after the FDA’s Circulatory System Devices panel voted 7 to 1 in favor of Cameron Health’s subcutaneous implantable cardioverter-difibrillator (S-ICD) system.
Circulatory support technologies gained a win April 25, when FDA’s Circulatory System Device Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the HeartWare Ventricular Assist System as a bridge to transplant device in patients with end-stage heart failure.
The FDA has cleared the latest version of GE Healthcare’s Vivid E9 cardiovascular ultrasound system.
To lay the groundwork for the April 26 Circulatory System Devices advisory panel meeting, the FDA has made trial results of Cameron Health’s subcutaneous implantable cardioverter-defibrillator system (S-ICD), the first not to require implantation of an electrode on or in the heart, available to the public.
Roche Diagnostics Operations has initiated a Class 1 recall for its Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays.
TomTec Imaging Systems has received FDA 510(k) clearance for its 2D Cardiac Performance Analysis MR software.
From a bipartisan duo in the Senate comes a 244-page bill with language calling on the U.S. Department of the Health and Human Services (HHS) to put forth a final unique medical device identifier rule sooner rather than later.
U.S. Senators Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) have introduced the Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS’ FDA) Act, a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.
