A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

Number of vessels transected with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt.

Number of vessels transected with diameter >5 to 7 mm with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Number of participants using HARMONIC 1100 Shears for sealing and transection of lymphatic vessels as assessed by Surgeon Satisfaction Scale Score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for sealing and transection of lymphatic vessel by HARMONIC 1100 Shears.

Number of vessels transected with hemostasis (Grade 1 to 4) based on hemostasis grading scale was reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Number of Grade 4 vessel transections requiring hemostasis measures such as hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products and other products were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products). Since multiple responses were collected, sum of the data of each category exceeds the overall number of units analyzed.