This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: PulseRider® Aneurysm Neck Reconstruction Device ("PulseRider")
HDE Applicant: Pulsar Vascular, Inc.
Address: 130 Knowles Drive, Suite E, Los Gatos, CA 95032
Approval Date: June 19, 2017
Approval Letter: Approval Letter
What is it? The PulseRider is a permanent nitinol (nickel titanium) self-expanding stent implant for the treatment of wide-necked aneurysms located at or near branching areas of arteries in the brain. The device's Y or T shape provides support for the placement of neurovascular embolic coils (flexible strands of thin coiled wire that assist clot formation within an aneurysm) and hold them in place inside the aneurysm.
How does it work? During a neurovascular intervention procedure, a health care provider uses a microcatheter to position the PulseRider across the aneurysm neck to create a bridge, and places several coils into the aneurysm to reduce blood flow into the aneurysm. The coils remain inside the aneurysm, and a clot will form around them, making it difficult for blood to enter the aneurysm.
When is it used? This device is indicated for use with neurovascular embolic coils in patients ≥ 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths ≥ 4 mm or dome to neck ratio
What will it accomplish? The PulseRider supports embolic coils by holding them in place within the aneurysm sac while maintaining the tubular structure of blood vessels.
In a clinical study of 34 patients, 87.9% had sufficient blockage of the aneurysm at the 6 month follow-appointment.
When should it not be used?
The PulseRider should not be used in patients with:
- Allergies to nickel.
- Bleeding disorders, or with contraindications to antiplatelet or anticoagulant therapy.
The PulseRider should not be used when the patient's vascular anatomy or dimensions at the targeted treatment site are not appropriate for the device.