2007-05-21

Stroke, Death, and TIA Rates Significantly Reduced With Closed-Cell Carotid Stents


Paris (ots/PRNewswire) -

- Data From Multicentre Registry Show Significant Benefit WithClosed-Cell Stents in the Treatment of Carotid Artery Stenosis

Boston Scientific Corporation (NYSE: BSX) welcomed results from alarge independent registry confirming the benefit of closed-cellstents in patients with carotid artery stenosis. The results,published in the February 2007 issue of the European Journal ofVascular and Endovascular Surgery, show that symptomatic patientstreated with closed-cell stents had significantly fewer complicationsafter the stent was implanted than patients who received open-cellstents. In particular, the Carotid WALLSTENT(TM) was used in 66% ofpatients in the registry and had the lowest 30-day post-proceduralevent rate of 1.2% in symptomatic patients.(1)

The 3,179 patients with carotid artery stenosis (narrowing of thearteries in the neck supplying blood to the brain) included in theregistry experienced significantly fewer strokes, deaths or transientischaemic attacks (TIA) within 30 days of the procedure if theyreceived a closed-cell stent (P = 0.002). These stents cover more ofthe artery wall than open-cell stents because they have overlappingor fully connecting struts, and have less space between struts (asmaller free cell area). A free cell area of less than 2.5 mm(2) wasassociated with a post-procedural complication rate of 1.2%,compared with 3.4% for a free cell area of more than 7.5 mm(2) (P =0.006).(1)

The differences were even greater in patients with symptomaticdisease who had already suffered a TIA or stroke and were at higherrisk of having another event. In these patients, the post-proceduralevent rate was 1.3% for closed-cell stents (< 5 mm(2) free cellarea), compared with 6.3% for open- cell stents (> 5 mm(2) free cellarea) (P < 0.0001).(1) The post-procedural rates for free cell areasof < 2.5 mm(2) and > 7.5 mm(2) were 1.2% and 7.0%, respectively (P <0.0001).(1)

Lead investigator Dr. Marc Bosiers, from the Department ofVascular Surgery, St Blasius Academic Hospital, Dendermonde, Belgium,explains the importance of these results: "After carotid angioplastyand stenting, patients are at risk for post-procedural complicationswithin 30 days of the procedure. Closed-cell stents, with theirsmaller free cell area, provide better scaffolding and lesioncoverage and were shown to reduce post-procedural adverse events inour study. In the symptomatic population, late complication rateswere highest for the open-cell stents and increased with larger freecell area. For the time being, consideration should be given to theuse of stents with a small free cell area, especially in symptomaticpatients."

About 4-8% of the population has advanced carotid arterydisease,(2) Which puts them at high risk of a TIA or stroke. TIAsinvolve stroke symptoms lasting only a few minutes or hours andprovide an important clinical indicator for potential future stroke,with 10-20% of sufferers having a full-blown stroke within amonth.(3) Approximately one-third of people who have had a strokedie within a month and one-third are left with disabilities.(4)

Carotid artery stenting is a minimally invasive procedure in whicha stent is delivered to the site of the blockage and expanded to openthe carotid artery and restore blood flow. Stents are tiny wire meshtubes that are inserted into arteries to help keep the vessel openand therefore maintain blood flow. Closed-cell stents, such as theCarotid Wallstent(TM) and the NexStent(TM) Carotid Stent, haveoverlapping or fully connecting struts, so they have less free cellarea and cover 5-10 times more of the artery wall than open-cellstents.

The registry recorded outcomes from carotid stenting using a rangeof closed- and open-cell stent devices at four centres in Belgium andItaly. The closed-cell stents included the Carotid WALLSTENT(TM)(1.08 mm(2) free cell area), Xact(R) (2.74 mm(2)) and NexStent(TM)(4.07 mm(2)). The open-cell stents included Precise(R) (5.89 mm(2)),Exponent(R) (6.51 mm(2_), Protégé(R) (10.71 mm(2)) and Acculink(R)(11.48 mm(2)).(x) The Carotid WALLSTENT(TM) was the most frequentlyused stent and was placed in 2,107 of the 3,179 patients.(1)

"As a leader in the field of cardiovascular device technology,Boston Scientific is delighted that this independent registryconfirms the value of closed-cell stents, such as the CarotidWALLSTENT(TM) or the NexStent(TM), which provide excellentscaffolding and lesion coverage", said Jeff Goodman, President ofBoston Scientific International. "Our Carotid stents offer a triplecombination of benefits for the patient: optimal scaffolding, celldesign and radial force."

Boston Scientific Corporation is a worldwide developer,manufacturer and marketer of medical devices whose products are usedin a broad range of interventional medical specialties. For moreinformation, please visit www.bostonscientific.com.

This press release contains forward-looking statements. BostonScientific wishes to caution the reader of this press release thatactual results may differ from those discussed in the forward-lookingstatements and may be adversely affected by, among other things,risks associated with new product development and commercialization,clinical trials, intellectual property, regulatory approvals,competitive offerings, Boston Scientific's overall business strategy,and other factors described in Boston Scientific's filings with theSecurities and Exchange Commission.

References

(1) Bosiers M, de Donato G, Deloose K, et al. Does free cell areainfluence the outcome in carotid artery stenosis. Eur J Vasc EndovascSurg 2007;33:135-141.

(2) Dodick DW, Meissner I, Meyer FB, Cloft HJ. Evaluation andmanagement of asymptomatic carotid artery stenosis. Mayo Clin Proc2004;79:937-944.

(3) The Stroke Association. Stroke statistics sheet R11http://www.stroke.org.uk/information/our_publications/factsheets/r11_stroke.html (last accessed 21 May 2007). (Due to the length of thisURL, it may be necessary to copy and paste this hyperlink into yourInternet browser's URL address field. Remove the space if oneexists.)

(4) Global burden of stroke. WHO Atlas of Heart Disease and Stroke2004. http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf (last accessed 21 May 2007).

(x)Carotid WALLSTENT and NexStent are trademarks of BostonScientific Corporation. Xact and Acculink are trademarks of AbbotLaboratories. Precise is a trademark of Cordis Corp. Exponent is atrademark of Medtronic Vascular, Inc. Protégé is a trademark of ev3,Inc.

ots Originaltext: Boston Scientific CorporationIm Internet recherchierbar: http://www.presseportal.de

Contact:Contact: Géraldine Varoqui, Boston Scientific PR Manager International, Tel: +49-2102-489-461, varoquig@bsci.com or Tracy Paul, BSC press office, Tel: +44-20-7413-3101, tpaul@medicalknowledgegroup.com

Boston Scientific Corporation

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Stroke, Death, and TIA Rates Significantly Reduced With Closed-Cell Carotid Stents

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