Guidant Corp. Receives FDA Approval for Minimally Invasive Carotid Stent System

Strategic Insights -

Guidant Corp. has announced U.S. Food and Drug Administration (FDA) approval of the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System, designed to reduce the risk of stroke associated with carotid artery disease. This approval marks the first time a carotid stent and embolic protection system have received FDA clearance. The minimally invasive treatment alternative to conventional open carotid artery surgery is intended for patients who are at high surgical risk. Carotid artery disease involves the buildup of plaque in one or both carotid arteries in the neck, affecting vital functions such as thinking, speech, and sensory and motor functions.

Key Takeaways:

  • The RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System are the first carotid stent and embolic protection system to receive FDA clearance.
  • The system is designed to reduce the risk of stroke associated with carotid artery disease, which involves the buildup of plaque in one or both carotid arteries in the neck.
  • The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient's neck and artery to remove plaque from inside the vessel wall.
  • The RX ACCULINK Stent demonstrated benefits for high surgical-risk patients in clinical trials.
  • Guidant's rapid-exchange technology provides an easy-to-use platform for treating patients with carotid artery disease.
  • The system is intended for patients who are at high surgical risk, providing a minimally invasive treatment alternative to conventional open carotid artery surgery.
  • William Gray, MD, director of endovascular care at the Swedish Medical Center in Seattle, Washington, and an executive committee member overseeing the clinical trials, praised the system for its ease of use and reported benefits for high surgical-risk patients.
  • The development of the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System is a result of extensive clinical trials and FDA approval.

Statistics:

  • The RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System are the first carotid stent and embolic protection system to receive FDA clearance.
  • The system is designed to reduce the risk of stroke associated with carotid artery disease, affecting an estimated 5 million Americans.
  • Traditional surgical treatment for carotid artery disease usually involves general anesthesia and an incision in the patient's neck and artery, with 2-5% of patients experiencing neurological symptoms, and 1-3% experiencing permanent damage.
  • Guidant's rapid-exchange technology provides an easy-to-use platform for treating patients with carotid artery disease, with a reported 95% success rate in clinical trials.

Sources:

  • NewsRx.com & NewsRx.net (2004 OCT 4)
  • Guidant Corp. press release (2004 OCT 4)
  • Cardiovascular Week editors (2004)