Boston Scientific Corporation today announced that patients treated with the Carotid WALLSTENT™ Monorail™ Endoprosthesis (Carotid WALLSTENT) have a significantly lower incidence of hypotension (abnormally low blood pressure) compared with patients treated with slotted-tube nitinol stents. Results from the new study were presented by Dr Barry T. Katzen at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recently held in Rome. The overall incidence of hypotension (procedural and 24-hour post-procedure) was 19.4 percent in Carotid WALLSTENT recipients compared with 40.4 percent in slotted-tube nitinol stent recipients (p=0.014). The incidence of periprocedural hypotension (24-hour post-procedure) was 12.9 percent in Carotid WALLSTENT recipients compared to 31.0 percent in slotted-tube nitinol stent recipients (p=0.045).

  "As carotid artery stenting becomes a mature technique, it is important to look at the subtle differences between technologies that could affect patient care," said Dr Barry T. Katzen, Medical Director, Baptist Cardiac & Vascular Institute, Miami, Florida, and the study's principal investigator.  "There is clearly a difference with the Carotid WALLSTENT in this study."

  The single-centre, retrospective study examined 172 patients with de novo carotid artery lesions, 31 of which received the Carotid WALLSTENT. The remaining patients received slotted-tube nitinol stents, which included ACCULINK™, Precise™, SMART, Xact® and VIVEXX™*.

  Carotid artery stenting is a minimally invasive procedure that involves a combination of balloon angioplasty and stenting to unblock and reopen the carotid artery in patients with carotid artery disease. Hypotension - a clinical event in which arterial blood pressure is abnormally low - commonly occurs during and after the procedure with reported incidences of up to 30 percent and has been attributed to stretching of the carotid sinus during the stenting procedure. If hypotension is associated with bradycardia - a type of arrhythmia in which the heart beats more slowly than it should - and cannot be resolved by deflating the angioplasty balloon, asking the patient to cough or administering atropine or a bolus of fluid, a pacemaker may be required. Very elderly patients are at increased risk of experiencing hypotension associated with bradycardia. There is evidence that periprocedural hypotension places patients at a higher risk for transient ischemic attack, stroke, myocardial infarction, or death.1

  "These excellent results continue to demonstrate why the Carotid WALLSTENT Endoprosthesis maintains the number one market share position outside the United States, where a number of companies offer only slotted-tube nitinol carotid stents," said Jeff Goodman, President Boston Scientific International. "Physicians now have further clinical evidence of the advantages of choosing the Carotid WALLSTENT Endoprosthesis when treating their patients."

  The Carotid WALLSTENT Endoprosthesis is a self-expanding stent composed of biomedical grade cobalt-chromium-iron-nickel-molybdenum alloy (commonly known as Elgiloy™** or Conichrome™***) wires braided in a tubular mesh configuration with an optimal low outward radial force to prevent the incidence of hypotension. Slotted-tube nitinol stents are self-expanding stents that are laser-cut from nitinol tubes and exhibit a high outward radial force which may be the leading cause for a higher incidence of hypotension. Flat-sheet nitinol stents (NexStent™ Carotid Stent) are self-expanding stents that are laser-cut from nitinol flat-sheets and exhibit a low outward radial force that may prevent the incidence of hypotension.

  Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: bostonscientific.

  This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, litigation, the Company's overall business strategy and other factors described in the Company's filings with the Securities and Exchange Commission.

    References

  1. Gupta R, et al. Hemodynamic instability after carotid artery angioplasty and stent placement: a review of the literature. Neurosurg Focus 2005;18:e6.
  * ACCULINK™ and Xact® are registered trade marks of Abbott Laboratories, Precise™ is a registered trademark of J&J - Cordis and VIVEXX™ is a registered trademark of Bard Inc.
** Elgiloy™ is a trademark of Elgiloy Ltd Partnership
*** Conichrome™ is a trademark of Carpenter technologies