Covidien, a healthcare products company, has gained 510(k) clearance from the US FDA for the iDrive Ultra powered stapling system.
The reusable, battery-operated endoscopic surgical stapling system with one-handed push-button is designed to eliminate the need for manual firing force and improve manoeuvrability.
Covidien Surgical Solutions vice president and chief technology officer Paul Hermes said the stapling system was developed in consultation with surgeons.
"We work closely with surgeons to develop products that not only improve patient outcomes, but also make surgery safer, easier and more efficient for surgeons," Hermes said.
"The iDrive Ultra powered stapling system is another example of Covidien’s dedication to innovation and to advancing clinically proven solutions."
The iDrive Ultra system leverages the Tri-Staple reloading technology, which provides less stress on tissue during compression and clamping, potentially improved perfusion into the staple line and the ability to manage tissue variability.
The iDrive Ultra system, designed for multi-patient use, is compatible with the company’s portfolio of Endo GIA reloads with Tri-Staple technology for use in laparoscopic and open surgical procedures.
"The iDrive Ultra powered stapling system will enable surgeons to operate through restricted anatomical space with greater precision, compared with traditional endomechanical staplers," Hermes added.
The company will make the system, which offers an environmentally friendly benefit by reducing medical waste, available in the US at the beginning of the fourth quarter of 2012.