Aesculap received FDA approval for the Caiman 12 Seal and Cut Technology System on November 23, 2020.
The device is a vessel sealer designed for laparoscopic or open surgery, utilizing bipolar electrosurgical radiofrequency (RF) energy. The instruments seal vessels by applying the energy to vessels or other tissue that is compressed between the jaws of the device, which can then be divided by actuating a cutting blade. On each jaw of the device there are side by side electrodes used to seal tissue with space between the electrodes for the cutting blade. The jaws are designed to compress the tissue from the tip of jaws first to prevent the tissue from slipping out of the jaws and to create uniform tissue ligation. This allows it to seal vessels up to 7 mm. This approval by the FDA was specifically for the 12 mm diameter instrument, although various 5 mm configurations are also available.
The use of bipolar electrosurgical RF energy devices to ligate and divide tissues has been previously established, and the FDA has allowed the Caiman 12 Seal and Cut Technology System to be marketed after determination that the device was substantially equivalent to predicate devices, citing a previous version of the Caiman Seal and Cut Technology System. Previous similar devices would include Ligasure (Medtronic) and Ensure (Ethicon).
The Caiman Seal and Cut Technology System is indicated for both open and laparoscopic surgery. The indications for use include gynecological, urologic, vascular, thoracic, thoracoscopic, and general surgical procedures. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed.
Tubal sterilization or tubal coagulation for sterilization is specifically excluded from the approval and is contraindicated.
References:
Campagnacci, R., de Sanctis, A., Baldarelli, M. et al. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc 21, 1526–1531 (2007). https://doi.org/10.1007/s00464-006-9143-2
Cassini, D., Miccini, M., Gregori, M. et al. Impact of radiofrequency energy on intraoperative outcomes of laparoscopic colectomy for cancer in obese patients. Updates Surg 69, 471–477 (2017). https://doi.org/10.1007/s13304-017-0454-8