Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.

Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.

Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.

Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients

The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.

2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.

Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.

The re-intervention rate was assessed in the evaluable cohort of 55 patients.

Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.

49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.

Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.

34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.

Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.

23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.

Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.

45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.

Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.

45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.

Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).

34 patients reached the Month 3 follow up point and were evaluated for stent patency.

Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).

23 patients reached the Month 6 follow up point and were evaluated for stent patency.

Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.

Only 1 subject experienced stent occlusion during the study.

Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.

The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.