Flexiva Pulse Registry

In HoLEP procedures: Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3 month follow-up, on a scale of 0 to 35.

Time frame: 3 month follow-up

Population: Change in IPSS total score in BPH subjects from baseline to 3 month post procedure was analyzed. If multiple IPSS scores were collected during the analysis window, only the last IPSS score collected in the window was counted. Visits that occurred from 60 days through 150 days post-operative were considered as 3-month visits. IPSS cannot be obtained in catheterized subjects; 30 subjects had catheters at baseline. 57 subjects had data at both baseline and 3 months post procedure.

The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures.

Time frame: Up to 60 days of follow-up for Lithotripsy Cohort

Population: The primary analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the lithotripsy procedure attempted.

The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures.

Time frame: Up to 240 days of follow-up for BPH Cohort.

Population: The primary analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted.

In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up. Stone free was defined as clinically nonsignificant, non-obstructive residual fragments of ≤ 3 mm, asymptomatic, and no auxiliary procedures performed between the final Flexiva Pulse holmium laser lithotripsy procedure and the 1-month follow-up.

Time frame: 1 month follow-up

Population: The proportion of subjects who achieved stone clearance at 1 month follow-up post lithotripsy procedure was calculated. The analysis used all available cases and the last available visit data was analyzed if multiple post operative visits occurred.

For Lithotripsy procedures: • Ability of the laser fiber to deliver energy as measured by whether or not the Lithotripsy procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form.

Time frame: Through lithotripsy procedure completion, up to 1 day.

Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.

For HoLEP procedures: Ability of the laser fiber to deliver energy as measured by whether or not the HoLEP procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form.

Time frame: Through HoLEP procedure completion, up to 1 day.

Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.

For HoLEP procedures: Improvement in Quality of Life (QoL) from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3-month follow-up, on a scale of 0 to 6.

Time frame: Up to 3 month follow-up

Population: The primary analysis was performed for the Intent to Treat (ITT) population where the IPSS QoL score was available at baseline and at 3 months post procedure. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted. IPSS QoL score was available for 41 subjects at both timepoints.

For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up

Time frame: Up to 3 month follow-up

Population: The analysis was performed for the Intent to Treat (ITT) population where Qmax was available at baseline and at 3 months post procedure. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted. Qmax was available for 58 subjects at both timepoints.

For Lithotripsy procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form.

Time frame: Through lithotripsy procedure completion, up to 1 day.

Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.

For HoLEP procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form.

Time frame: Through HoLEP procedure completion, up to 1 day.

Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.

For HoLEP procedures: • Hemostasis measured by ability to coagulate during HoLEP procedure. Tool used will be a yes or no question on the case report form.

Time frame: Through HoLEP procedure completion, up to 1 day.

Population: The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted.

Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: * Perforation: For Lithotripsy procedures: anywhere in urinary tract. * Hemorrhage resulting in blood loss of ≥ 500mL * Burn

Time frame: Up to 60 days of follow-up for Lithotripsy Cohort

Population: The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the lithotripsy procedure attempted. There were no reports of perforations, hemorrhages, or burns in the Lithotripsy cohort.

Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: * Perforation: For HoLEP procedures: in prostate capsule, bladder, and/or urethra * Hemorrhage resulting in blood loss of ≥ 500mL * Burn

Time frame: Up to 240 days of follow-up for BPH Cohort.

Population: The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the lithotripsy procedure attempted. There were no reports of perforations or burns in the BPH cohort; 2 hemorrhages occurred in the ITT population.