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Matrix coating improves drug-eluting balloon catheter performance

B.Braun Melsungen : 25 October, 2007  (New Product)
Results of the PEPCAD I and II studies have demonstrated the superiority of the drug-eluting balloon SeQuent Please compared with the Taxus drug-eluting stent for the first time.
The results were presented by Dr Martin Unverdorben (Rotenburg, Germany) at the TCT conference on October 24, 2007.

In 20 to 40 percent of cases with coronary Stent implantations, a re-narrowing of the vessel occurs after six months. Drug eluting stents (DES) are currently being implanted in order to prevent restenosis. Early results are encouraging, however, some cases of restenosis and death have been reported already.

Recent studies have shown that DES can be effective in preventing the coronary vessels from narrowing again, but also that this entails a higher risk of Stent thrombosis.

The polymer coating of DES might be responsible for an increased rate of late Stent thrombosis compared to conventional bare metal stents. With the novel drug-eluting balloon catheter, SeQuent Please, the drug Paclitaxel is applied to the vascular wall by means of a ‘matrix coating’ from the balloon surface.

According to the first pilot study, published in the New England Journal of Medicine (Scheller et al, NEJM 2006), this method of releasing the drug appears as safer and more effective than via an uncoated balloon.

PEPCAD II has been initiated for randomised comparison of the coated balloon (66 subjects) with a paclitaxel-eluting DES (60 subjects). As the primary endpoint of the study, the late loss at six months for SeQuent Please was 0.19mm and significantly lower than 0.45mm for the Taxus Stent with 4.8 percent major adverse cardiac events (MACE) vs. 22.0 percent for the Taxus stent.

Dr Unverdorben also presented the results from the PEPCAD I study enrolling 120 subjects for treatment of small vessel disease. So far, the coated balloon has been used only for treatment of in-stent restenosis.

PEPCAD I is the first study investigating the mechanism of action of the new development SeQuent Please for dilatation of native arteries not previously stented.

At six months follow-up, the patients solely treated with the coated balloon (82 subjects) experienced an in-segment restenosis rate of 5.5 percent and 6.1 percent MACE. These results compare quite favourably with previously published results using DES for the treatment of small vessel disease.

B. Braun Melsungen has signed a license agreement with the Charite Hospital (Berlin, Germany) regarding the further development and marketing of this new procedure for treating narrowed coronary vessels.

Paclitaxel is applied to the vascular wall by the balloon Catheter by means of a ‘matrix coating’ using a physiologically harmless, inactive excipient.

The publication of the pilot study in the NEJM has already spawned a number of imitators citing the successful findings of the study without presenting any data of their own. These products have a different coating, which is not comparable with the effectiveness of the matrix coating. Accordingly, the findings of the studies cannot be applied to these imitation products.

With its PEPCAD I-V studies, B. Braun has launched an extensive range of research projects with a view to clinically documenting the safety and effectiveness of the matrix coating that has been licensed to it by the Charite, and to build upon its leading position in the new product segment of drug-eluting balloon catheters.

Cardiovascular disease is the number one cause of death in the western world. Angina pectoris and myocardial infarction are the typical symptoms of coronary artery stenosis. Treatment involves the implantation of stents with or without a drug coating. A drawback of DES is that, because of drug release, the artery does not always heal completely after a number of months.

These side effects have not been observed to date with the coated balloon. The results of PEPCAD I and II confirm the safety and efficacy of SeQuent Please in the treatment of both native and restenosed arteries. B. Braun expects, that the coated balloon alone or in combination with a bare metal Stent could augment or even replace the DES for a wide range of indications.

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