Covidien's 3-in-1 laparoscopic surgical instrument obtains FDA 510(k) certification-MassDevice

2021-12-06 07:51:40 By : Ms. cherry chan

Medical Device Business Magazine-Medical Device News and Articles | Massive Devices

Covidien (NYSE: COV) announced this week that its LigaSure Maryland jaw opener/laparoscopic sealer/divider has received 510(k) clearance from the FDA.

The Maryland device is part of Covidien's LigaSure series of vessel sealing technologies. The device aims to increase the efficiency of surgery by reducing the number of surgical tools required. The device combines 3 types of surgical instruments—Maryland dissector, atraumatic tissue grasper, and cold surgical scissors—that can be grasped, cut, and sealed without the need to change instruments.

The device has also been approved for marketing in Europe and comes in 3 different sizes. Covidien plans to release a 37 cm model this quarter. The company expects to start selling two other sizes, 23 cm and 44 cm later this year.

"For more than 15 years, surgeons have relied on LigaSure technology because it reduces blood loss, shortens operation time, and shortens hospital stays compared to sutures," said Chris Barry, Senior Surgery President, in a prepared comment. "LigaSure Maryland Jaws provides surgeons with an efficient, versatile and versatile one-step sealing option, and further demonstrates Covidien's commitment to expanding energy equipment options with solutions tailored to specific procedures and surgeons' use needs."

The FDA's victory is good news for Covidien. Covidien announced earlier this month that it would shut down its OneShot renal denervation device. The company said that behind this move is the slow development of the hypertension market. A recent sign is the disappointing Symplicity HTN-3 research results of rival renal denervation equipment manufacturer Medtronic (NYSE: MDT). Criticized.

Filed Under: News Well, Regulatory/Compliance Tagged as: Covidien, Minimally Invasive Surgery

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