Medtronic plc has received the first FDA approval for a transcatheter pulmonary valve to treat patients whose bioprosthetic pulmonary heart valves have failed. For these congenital heart disease patients, many of whom undergo repeat open heart surgeries as children and into adulthood, this validates the use of the Melody Transcatheter Pulmonary Valve (TPV) to avoid additional surgical procedures. BEYOND OFF-LABEL USE The Melody TPV has long been used off-label in this indication, but a retrospective study underlying the approval found that it's effective even in pediatric and adult patients with a smaller valve. It is...

Medtronic plc has received the first FDA approval for a transcatheter pulmonary valve to treat patients whose bioprosthetic pulmonary heart valves have failed. For these congenital heart disease patients, many of whom undergo repeat open heart surgeries as children and into adulthood, this validates the use of the Melody Transcatheter Pulmonary Valve (TPV) to avoid additional surgical procedures.

Medtronic plc has had a couple of failed trials in below-the-knee peripheral arterial disease (PAD) with its drug-coated balloon (DCB) technology. Now, the Dublin, Ireland-based med-tech giant is giving it another shot with a small, European study using improved technology and clinical trial design. The results, expected in 2020, could offer initial evidence that DCBs can provide enough long-lasting vessel patency to improve wound healing in tough-to-treat patients. Competitor C.R. Bard Inc. is the only company with an ongoing IDE trial for a DCB in arteries below the knee. "We have a lot of history...

Medtronic plc had one failed trial in below-the-knee peripheral arterial disease (PAD) with a previous drug-coated balloon (DCB) technology. Now, the Dublin, Ireland-based med-tech giant is giving it another shot with a small, European study using improved technology and clinical trial design.

Tryton Medical Inc. has garnered an FDA approval for its Side Branch Stent to treat coronary artery disease with lesions at major branches. This is the first approval for a dedicated bifurcation device in the U.S., according to the Durham, N.C.-based company. Cordis, part of Dublin, Ohio-based Cardinal Health Inc., has already signed a deal to be the sole U.S. distributor of the stent. The Cordis deal dates back to last October, and the group is slated to launch the Side Branch Stent via its interventional vascular business later this month. Although the financial details...

Tryton Medical Inc. has garnered an FDA approval for its Side Branch Stent to treat coronary artery disease with lesions at major branches. This is the first approval for a dedicated bifurcation device in the U.S., according to the Durham, N.C.-based company. Cordis, part of Dublin, Ohio-based Cardinal Health Inc., has already signed a deal to be the sole U.S. distributor of the stent.