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SeQuent® Please product description
SeQuent® Please is a drug eluting balloon (DEB) with successful proof of efficacy in
the treatment of narrowing of the coronary arteries. SeQuent® Please is used in the
same way as a coronary balloon catheter for balloon expansion of narrowing of the
blood vessels (stenosis). Unlike conventional balloon catheters, SeQuent® Please also
releases a drug from the balloon surface that is absorbed by the surrounding wall of the
blood vessel. The drug is paclitaxel, which has been studied extensively in clinical trials
and is also used for drug eluting stents (DES).
To enhance transfer of the drug to the vessel wall, the paclitaxel in SeQuent® Please is
embedded in an x-ray contrast medium matrix (iopromide). This technology delivers a
sufficient dose of drug from the balloon surface to the vascular wall after a brief contact
period of just a few seconds. Paclitaxel inhibits the growth and spread of smooth
muscle cells over a prolonged period and so prevents the expanded artery from closing
in again due to cell growth.1 The matrix is bioabsorbable and dissolves completely after
use. No foreign bodies remain at the intervention site, thereby minimizing the risk of
thrombosis.
Benefits of SeQuent® Please
SeQuent® Please is a new treatment option in coronary artery therapy with significant
benefits. Unlike stent implantation, no foreign bodies remain in the artery with the new
system. The drug eluting balloon also reaches narrowed areas that would not be
accessible for stent treatment, such as, for instance, very small blood vessels,
bifurcations and very long areas of stenosis. SeQuent® Please is associated with a
significantly lower incidence of re-stenosis of expanded arterial segments. In addition,
the required length of treatment with platelet inhibiting drugs (platelet aggregation
inhibitors) is much shorter after the new procedure than after DES implantation. With
the latter, patients generally required treatment for as long as 12 months after the
procedure. With SeQuent® Please, a treatment period of no longer than three months
is sufficient. This is associated with significantly lower treatment costs. SeQuent®
Please thus has the potential to bring about a paradigm shift in the treatment of
vascular restenosis.
Study data on SeQuent® Please
When coronary artery disease (CAD) is treated with an uncoated stent, the artery
narrows again over time in as many as 30 percent of cases, and this occurs at the stent
implantation site. In-stent restenosis, as it is called, can be expanded either with a
balloon catheter or by the implantation of a second stent into the existing one.
However, there is a high likelihood of recurrence of restenosis in both cases.2
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To establish whether a paclitaxel eluting balloon catheter reduces restenosis, in-stent
restenosis in 52 patients was treated either with a novel drug eluting balloon (DEB) or
with a conventional uncoated balloon. Result: re-narrowing occurred within six months
in only 5 percent of DEB patients versus 43 percent of patients treated with the
conventional uncoated balloon.2
Another study showed that the drug eluting balloon is significantly superior to drug
eluting coronary stents. Again, subjects in this clinical trial had in-stent restenosis. In
this study, however, one half of patients were treated with a paclitaxel eluting stent,
while the other half underwent expansion with SeQuent® Please. At six months after
the intervention, only 6.7 percent of the SeQuent® Please patients versus 20.4 percent
of paclitaxel eluting stent recipients required re-intervention.3 The positive study
findings are already reflected in the guidelines of the German Society of Cardiology
(DGK).4
Good results were also obtained for the use of SeQuent® Please to treat stenosis of
small arteries, with restenosis rates of only 5.5 percent in patients treated with
SeQuent® Please alone. Considerably higher percentages have been observed in
similar studies of drug eluting coronary stents in this therapeutic indication.5 Further
applications for SeQuent® Please are currently being investigated by B. Braun
Melsungen AG in an extensive study program.
Development of SeQuent® Please
SeQuent® Please was developed by two German professors, Ulrich Speck and Bruno
Scheller. Speck and Scheller started working on the idea in late 1999 in a close
research alliance between the Experimental Radiology department of Charité Mitte
hospital in Berlin and Internal Medicine III department, Homburg an der Saar hospital.
DEB research is based on the surprising discovery that prolonged drug elution is not
necessary in order to prevent restenosis on a long-term basis. In the course of their
research, the scientists discovered that x-ray contrast media significantly improve
absorption of paclitaxel into the vascular wall. On that basis, a method was developed
to coat a balloon with the drug paclitaxel in an iopromide matrix.1 The result was named
PACCOCATH and investigated in pilot studies. A licensing agreement with the medical
devices manufacturer B. Braun Melsungen AG enabled the further advancement of
PACCOCATH technology to serial production. The result is a clinically tested drug
eluting balloon catheter: SeQuent® Please.
Recipient of the 2008 Innovation Award
The Experimental Radiology department of Charité hospital and Innora GmbH in
cooperation with B. Braun Melsungen AG, Vascular Systems and Bayer Schering
Pharma AG received the 2008 Berlin Brandenburg Innovation Award last December on
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the grounds that the SeQuent® Please drug eluting balloon constitutes a fundamental
solution to the problem of post-intervention coronary artery restenosis.6
References:
1) Scheller B. Speck U: Der medikamentenbeschichtete Ballonkatheter PACCOCATH – von der Idee
zum klinischen Wirknachweis. magazin forschung (Universität des Saarlandes) 2/2007, 20-24
2) Scheller B. et al.: Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Ballon Catheter.
N Engl J Med 355; 20 (2006) 2113-2124
3) Unverdorben M.: Randomized comparison of the SeQuent Please balloon catheter versus the Taxus
stent in the treatment of in-stent restenosis--12-month follow-up of the PEPCAD II ISR study.
American College of Cardiology Scientific Sessions/i2 Summit-SCAI Annual Meeting; March 31, 2008;
Chicago, IL. Late breaking clinical trials.
4) Silber S. et al.: Medikamente freisetzende Koronastents (DES) und Medikamente freisetzende Ballonkatheter (DEB): Aktualisierung des Positionspapiers der DGK. Clin Res Cardiol 97 (2008) 548-563
5) Drug-Eluting Balloons May Be Alternative to Drug-Eluting Stents; FDAnews Device Daily Bulletin Oct.
26, 2007; Vol. 4; No. 211
Unverdorben M et al. in press: Paclitaxel-Coated Balloon Catheter versus Paclitaxel-Coated Stent
for the Treatment of Coronary In-stent Restenosis
6) http://www.innovationspreis-bb.de/
March 2009
Press contact
Dorothea Küsters Life Science Communications GmbH
Anna Jensen, Lars Bruhn
Leimenrode 29, D-60322 Frankfurt/Main
Phone: +49 (0) 69 - 61 998 -18 or -15
Fax: +49 (0) 69- 61 998 -10
Email: [email protected],
[email protected]
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Publisher
B. Braun Melsungen AG
Corporate Communications
Carl-Braun-Straße 1
D-34212 Melsungen
www.bbraun.com