RESUMO
OBJECTIVE: Current endoscopic transection devices are not optimized to meet the unique challenges posed by the task of vessel transection in difficult-to-access locations within the pleural cavity. The ECHELON FLEX™ powered vascular stapler (PVS) has been designed with four rows of staples instead of six, to decrease its size and enable more precise placement on fragile pulmonary vessels, using a narrower anvil than other commercially available transecting devices. This study was performed to determine whether the reduced number of staple rows affects haemostasis, and to assess surgeons' initial impression of the smaller stapler during in vivo usage. METHODS: The new four-row stapler was compared with commercially available six-row articulating staplers via expert graders using a validated scale of haemostasis in vivo after application on porcine gastroepiploic pedicles and other thin- and thick-walled vessels. The new stapler was then compared with current products by practising thoracic surgeons (n = 27) during in vivo usage of simulated pulmonary procedures in a porcine model. The surgeons were also surveyed on the key attributes of the four-row stapler in relation to the six-row predicates. RESULTS: Haemostasis evaluated on an ordered scale was clinically equivalent between the test and predicate staplers, and was deemed acceptable for all thin- and thick-vascular tissue applications. Surgeons found no difference in haemostasis between the four- and six-row staplers (P = 0.486), and judged the four-row stapler superior in terms of access, reduced need for dissection, reduced stress of surgeon and precise control (P < 0.001 for all). CONCLUSIONS: The new ECHELON FLEX™ PVS provides haemostasis equivalent to six-row staplers. With a smaller anvil, narrower shaft and wider angle of articulation, the PVS demonstrated improved access capability for pulmonary vessel procedures.