LapCap Used with Any Needle Length
Aragon Surgical, Incorporated has received approval from the FDA for their LapCap device to be used with any length of needle. This allows use of the LapCap device across the range of patients who are obese, including those patients who are morbidly obese.
During completion of most laparoscopic procedures, surgeons generally use a 12 cm long needle. In patients who are obese, particularly those that are morbidly obese, a longer needle may be required. In those cases, surgeons may instead employ a 15 cm needle. This new approval allows the LapCap system to be used with whichever needle the surgeon opts for.
With the LapCap system, surgeons have increased control over the initial needle passed through the abdominal cavity through which gas is instilled. Studies have indicated that with use of the LapCap device, surgeons place this needle correctly with 100 percent accuracy.
The LapCap has already been approved by the FDA, but that covered use of the device with 12 cm needles. An article describing utilization of such was posted on HospitalBuyer after data was presented at the Society of Laparoendoscopic Surgeons last fall.
January 29, 2008 Related topics: Product Approval & Certification, Surgery