Restenosis prevention continues to be a challenge in interventional cardiology. DES are well accepted in the prevention and therapy of coronary restenosis but concerns have been raised that DES while being effective in reducing restenosis may be associated with an increased incidence of late thrombotic complications or death.
Due to the limitations of the current available DES technology novel concepts need to be implemented to overcome those limitations, by avoiding a sustained drug release from polymers or other sustained release technologies.
The SeQuent® Please concept stands for a new delivery technology of a short term, single shot drug delivery with a higher dosage of paclitaxel, embedded in a bio absorbable carrier matrix.
Recent clinical trials have shown that this concept leads to a statistically reduced number of restenosis rate in comparison with the common used treatment options for ISR and SVD. Safety and efficacy of the concept is approved and evaluated based on the scientific data of Pre-clinicals (Scheller, Speck) and Clinicals (ISR I/II – first in man trials as well as the B. Braun PEPCAD clinical program (PEPCAD II for ISR and PEPCAD I for SVD).
Predictive product benefit due to “worst case study scenario”
The B. Braun PEPCAD program layout is based on the firm conviction that a new product concept has to be approved in a worst case environment (lesion/patient specific) to show its superiority.
Moreover, if a new concept is predominant in worst cases, benefits in “simple” cases can be automatically expected. The PEPCAD program does not only evaluate the novel DEB concept. In addition it evaluates the use of a drug eluting balloon combined with a premounted BMS as an alternative to the current available DES without any procedural (deliverability) or conceptual (polymer) limitations.
SeQuent® Please for small vessels, 6-months-angiographic follow-up and 12 months clinical follow-up GERMAN MULTICENTER TRIAL.
SeQuent® Please for the treatment of in-stent restenosis randomized with TAXUS paclitaxel eluting stent, 6-months-angiographic follow-up 12 months clinical follow-up GERMAN MULTICENTER TRIAL.
SeQuent® Please with subsequent Coroflex® Blue implantation for diabetics randomized with Taxus, 9-months-angiographic follow-up ASIAN MULTICENTER TRIAL.
SeQuent® Please for in-stent restenosis randomized with POBA, 9-months-angiographic follow-up Japanese MULTICENTER TRIAL.
Bifurcation pilot study, Coroflex® + SeQuent Please in main vessel and SeQuent® Please only for side branch, 9-months follow-up German MULTICENTER TRIAL.
The drug-eluting balloon as an alternative to drug-eluting stents, SeQuent® Please + Coroflex® Blue (CoCr BMS) randomized vs. Coroflex® Blue + SeQuent® Please, 6-months angiographic follow-up, MULTICENTER TRIAL in India.
SeQuent® Please – Indications