The contest between the two main classes of antiproliferatives for circulatory system use continues as seen in a presentation at this year’s Transcatheter Cardiovascular Therapeutics.

The days when paclitaxel was the subject of controversy in connection with peripheral artery disease (PAD) seem to be drawing to a close, thanks in part to a new drug-coated balloon (DCB) by Trireme Medical Inc., of Pleasanton, Calif. Trireme’s Chocolate Touch device, a second-generation DCB with paclitaxel as an antiproliferative, fared well against a legacy paclitaxel device, thus opening a new front in the competition in the PAD space and seemingly relieving any concerns about the safety of paclitaxel.

The FDA has granted approval to Urotronic Inc. for its Optilume urethral drug-coated balloon (DCB) for the treatment of male urethral strictures. The device inhibits new scar tissue growth that may form after endoscopic dilations via the controlled release of paclitaxel, an antiproliferative that inhibits scar tissue formation.

Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.

The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.

A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.

Medtronic plc reported promising results from a feasibility study of its In.Pact 0.014 drug-coated balloon (DCB) in critical limb ischemia (ICL) patients with chronic total occlusion (CTO) in the infrapopliteal arteries.

HONG KONG – Singapore-based Genesis Medtech International Pte. Ltd. has acquired the Chocolate Touch drug-coated balloon angioplasty asset from Pleasanton, Calif.-based Trireme Medical LLC. The drug-device technology asset in question is designed with the intention of providing a safer and more effective treatment for patients suffering from peripheral vascular disease, compared to traditional balloon angioplasty.

Medtronic plc is highlighting the publication of primary endpoint results from the In.Pact AV Access trial in the New England Journal of Medicine. The study found that the company’s paclitaxel-coated balloon limits the number of reinterventions needed to maintain blood flow in patients with end-stage renal disease who have arteriovenous fistulae.

Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, Stephen Ferguson, of Bloomington, Ind.-based Cook Group Inc., cited several problems he saw with the draft, including that one of the specifications for balloon fatigue testing exceeds the level spelled out in an international standard adopted by the FDA.