FDA Approves Covidien's LigaSure Maryland Jaw Device
Covidien announced that the FDA gave the green light for the company to manufacture and market their LigaSure Maryland Jaw - an open/ laparoscopic sealer/ divider and newest addition to the company’s vessel and tissue sealing product portfolio. The company also successfully completed all European requirements imposed on the product in order to CE Mark the product. According to the company, they will start marketing the product later in this quarter in the U.S. and Europe.
The LigaSure Maryland Jaw device is designed to offer maximum efficiency during laparoscopic and open surgery. Its unique energy sealing technology has been combined with the functionality of a Maryland Dissector, an atraumatic tissue grasper, and cold surgical scissors, the first of which is a blunt tool that is utilized by surgeons to manipulate tissue.
Chris Barry, President, Advanced Surgical at Covidien, recently stated, “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.” The LigaSure Maryland jaw offers surgeons an efficient, versatile and multifunctional 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 product has already found a prominent place in the industry having been used in over 8 million vessel sealing procedures globally. The company currently has plans to market the product in three lengths: 37 cm (which will be sold to a small group of customers early in the first quarter), 23 cm, and 44 cm. The device was designed with the intended use for minimally invasive indications. It will be used in the urologic, vascular and thoracic fields, as well as used for thoracoscopic and gynecological procedures.
Sources:
http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1892551&highlight=
http://surgical.covidien.com/products/vessel-sealing#technology