Covidien (NYSE:COV) won 510(k) clearance from the FDA for its LigaSure Maryland jaw open/laparoscopic sealer/divider, the company announced this week.
The Maryland device is a part of Covidien’s LigaSure family of vessel sealing technologies. The device aims to make surgeries more efficient by cutting down on the number of surgical tools needed. The device combines 3 surgical instruments – a Maryland dissector, atraumatic tissue grasper and cold surgical scissors – to grab, cut, and seal without switching utensils.
The device, which also has European marketing approval, comes in 3 different sizes and Covidien plans on releasing the 37cm model this quarter. The company expects to begin selling the other 2 sizes, 23cm and 44cm, later this year.
“For more than 15 years, surgeons have trusted LigaSure technology for its ability to reduce blood loss, shorten procedure time and shorten the length of hospital stay compared to sutures," advanced surgical president Chris Barry said in prepared remarks. "The LigaSure Maryland jaw offers surgeons an efficient, versatile and multi-functional option for one-step sealing and further demonstrates Covidien’s commitment to expand energy device options with solutions targeted at specific procedures and surgeon use needs."
The FDA win is good news for Covidien, which announced earlier this month that it’s shutting down its OneShot renal denervation device. The company cited slow development in the hypertension market behind the move, marked most recently by the foofaraw over rival renal denervation devices maker Medtronic’s (NYSE:MDT) disappointing Symplicity HTN-3 study results.
