Dr Yoshimitsu Soga (Kokura Memorial Hospital, Fukuoka, JP) discusses the 6-month results from the Lutonix® SFA Japan postmarket study (PMS), which aims to confirm the safety and efficacy of the Lutonix® 035 drug-coated PTA dilation catheter in a heterogeneous population. 

 

Questions:

1. Why was this study needed?

2. Can you describe the study design?

3. What data are you presenting at LINC 2020?

4. How should the results from this trial influence clinical practice?

5. What further research should be conducted with this device?

 

Filmed on location at the Leipzig Interventional Course 2020. 

 

Interviewer: Ashlynne Merrifield

Videographer: Natascha Wienand

 

Transcript Below :

Question 1 : Why was this study needed?

Unlike in Europe and the U.S. market, in Japan the only we have the two kind of the drug coated balloon. They have a such like efficacy, and efficacy and safety in the Japanese patient is needed. Therefore, the aim of the study is that. 

Question 2 : Can you describe the study design?

This study was performing as a multi-centered prospective single armed registry. We enrolled more than three hundred patients to treated through the Lutonix. 

Question 3 : What data are you presenting at LINC 2020?

Today I present the safety and the efficacy of the Lutonix there in the Japanese patient after the six months. This study, finally for up to one year however today I present the six month result. 

Question 4 : How should the results from this trial influence clinical practice?

Oh, well so, as I mentioned earlier, so Japanese physicians do not have much experience to use a drug coated balloon itself therefore, for Japanese market the critical physician needs that Japanese data for the DCB. Yeah, in the real world practise. 

Question 5 : What further research should be conducted with this device?

So, of course that longer term critical outcome is needed in terms of the safety and efficacy, there is a primary patency, the longer term primary patency is needed more.