After reviewing a handful of studies published since 2013 the American Heart Association/American Stroke Association (Dallas) has issued new guidelines for treating patients with clot-caused (ischemic) stroke. For the first time, the organization is recommending the use of a stent retrieval device to remove blood clots in select stroke patients who have clots obstructing the large arteries supplying blood to the brain. The new guidelines are published in the AHA journal Stroke.
The first drug-coated angioplasty balloon approved by the FDA showed superior primary patency over standard balloons at 12 months, but some industry analysts are skeptical about longer-term data. According to 12-month results published in The New England Journal of Medicine, the Lutonix 035 drug-coated balloon percutaneous transluminal angioplasty (PTA) catheter from C. R. Bard (Murray Hill, New Jersey) demonstrated superior primary patency over standard PTA in the LEVANT 2 study. LEVANT 2 was a single-blind randomized multicenter trial.
Transcatheter aortic valve replacement (TAVR) devices have stolen most of the valve replacement spotlight for the past few years, but in the background transcatheter mitral valve replacement (TMVR) technology has been quietly biding its time. And that time has arrived.
Precision medicine has attracted a lot of attention in the healthcare industry over the past several months, particularly since President Obama announced the administration's Precision Medicine Initiative (PMI) in January. While the term can be open to broad interpretation, most companies and other stakeholders seem to agree that the one-size-fits-all treatment approach is not good enough.
Though TransEnterix (Research Triangle Park, North Carolina) did not meet its original timeline of having FDA clearance by the end of 2014 for its laparoscopic surgical platform, CEO Todd Pope told Medical Device Daily that the extra time is paying off.
What started out as a couple of tubes and some duct tape put together in a surgeon's garage is now an FDA-cleared device for the most-performed bariatric surgery in the U.S. Amit Trivedi, a bariatric surgeon at Hackensack University Medical Center (Hackensack, New Jersey) told Medical Device Daily that the GastriSail was designed to improve the consistency and efficiency of sleeve gastrectomy procedures in obese patients.
Faced with fierce competition, price declines and reimbursement pressure in the U.S. Bayer (Leverkusen, Germany) has decided to duck out of the diabetes care market and focus on its life sciences organizations, primarily pharmaceuticals. The company said it plans to sell its diabetes business to Panasonic Healthcare (Tokyo) in a deal valued at €1 billion ($1.13 billion).
