Post-Marketing Experience With the Levalap™ 1.0: Improved Abdominal Access WHEN Using the Veress Needle During Laparoscopic Surgery

Abstract

Study Objective

The LevaLap™ 1.0 (Core Access Surgical Technologies, Atlanta, GA, USA) was designed to promote safer, more stable, and more predictable abdominal access when using the Veress needle for insufflation. Among other benefits, it increases the distance between the access site and retroperitoneal vessels by >5 cm. We report on the first post-marketing clinical study (PMCF) assessing experience with the use of the LevaLap™ 1.0 during gynecologic laparoscopic surgery.

Design

Prospective multicenter study.

Setting

Operating room.

Patients or Participants

Women ≥18 years old. Exclusion criteria: pregnancy, access site surgery in prior 10 days, abdominal hernia, contraindication to Veress needle or laparoscopy use, BMI >30 kg/m², and inability/unwillingness to provide consent.

Interventions

Use of the LevaLap™ 1.0 to facilitate abdominal access when using the Veress needle for insufflation.

Measurements and Main Results

157 subjects were studied by 9 surgeons, each performing ≥5 cases (5-22 cases/surgeon); mean age: 43.6±14.4 yrs. and mean BMI: 24.8±3.8 kg/m². Access site was 83.4% trans-umbilical, 15.3% peri-umbilical, 0.6% Palmer's point, and 0.6% other. Using the device, 96.8% (95% CI: 92.7%-99.0%, n=152/157) of patients’ access was successfully achieved at 1^st attempt and 99.4% (95% CI: 96.5-100.0, n=156/157) within the first two attempts. One minor device-related AE was reported: a circular redness on the skin at the site of device application, resolving spontaneously the following morning. Surgeons noted easier access in 58%, increased confidence in 68.5%, increased access control in 66.9%, and increased access efficiency in 66.2% of cases.

Conclusion

The results of this PMCF study indicate that the use of the LevaLap™ 1.0 resulted in easier, greater control and greater efficiency during abdominal access using the Veress needle. In 96.8% of patients access was achieved at 1^st attempt, and in 99.4% within the first two attempts. The use of the LevaLap™ 1.0 facilitates abdominal access when using the Veress needle for insufflation.