Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.

The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization.

Ra Medical Systems Inc., of Carlsbad, Calif., reported that the U.S. FDA has granted investigational device exemption (IDE) approval to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenosis.

Dublin-based Medtronic plc has snagged the U.S. FDA’s approval for its Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The company said it will begin rolling out the device at a limited number of medical centers in the upcoming weeks, with a full, nationwide launch sometime this spring. About the size of a large vitamin pill, the leadless Micra AV is indicated for the treatment of patients with AV block, a disorder that occurs when the electrical signal traveling from the atria, or upper chambers of the heart, to the ventricles, or lower chambers, is impaired.

The U.S. FDA has granted breakthrough device designation to Mojo Vision Inc. for its first-of-a-kind true smart contact lens. The Mojo Lens, which features “invisible computing” and a built-in display, enables people to get timely information without having to look away from what they are doing or glance at a screen.

Transenterix Inc., of Research Triangle Park, N.C., said Tuesday that it has filed a 510(k) submission with the U.S. FDA for the Intelligent Surgical Unit (ISU), a machine vision system designed to work with its robotic Senhance surgical system. The new technology would equip users of the Senhance system with augmented intelligence to improve performance and surgical outcomes.

Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.

The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.