SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.

SAN FRANCISCO – Mitraclip from Abbott Park, Ill.-based Abbott Laboratories, has long been the only minimally invasive mitral valve repair device that's approved by the FDA. Edwards Lifesciences Corp., of Irvine, Calif., aims to challenge that dominance with its Pascal. This week at the Transcatheter Cardiovascular Therapeutics (TCT) conference, positive one-year data from the small CLASP study on Pascal were presented, offering a further glimpse of data for comparison.

BOSTON – What are companies doing to be successful in the current environment of med-tech M&A valuation? That question was posed to panelists from three top device makers during the Medtech Conference Tuesday morning. Specifically, the panel, which featured representatives from New Brunswick, N.J.-based Johnson & Johnson, Medtronic plc and Boston Scientific Corp., looked at overall valuations across the sector, as well as what it takes to produce a successful M&A strategy.

BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.

Edwards Lifesciences Corp.'s buy of Cas Medical Systems Inc. (Casmed) this spring appears to have borne fruit. The Irvine, Calif.-based company reported that the U.S. FDA has granted clearance for a smart cable enabling compatibility between the company's Foresight tissue oximetry (brain oxygenation) sensors and the Hemosphere advanced monitoring platform.

Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low surgical risk, it’s tempting to think this device type has pretty much conquered all that lay before it. That’s not the case, however, as the question of bicuspid valve might be answered in a way that gives Edwards Lifesciences and Medtronic another sizeable patient population for their TAVR offerings. As is widely known, the FDA recently approved two TAVR devices each by Medtronic...