Product Information

The CloSys HD uses no foreign materials to seal the arteriotomy. Just as when manual compression is used, only the patients’ own deheparinized blood forms the clot that stops the bleeding from the arteriotomy. The diffence is that instead of taking 4-6 hours to stop the bleeding, the CloSys HD seals the arteriotomy safely and securely in 20 minutes. Extensive testing required by the FDA has established that there is no danger to the patient if deheparinized blood is inadvertently injected into general circulation.

The video below demonstrates how the HD works:

  • Immediately at the end of the procedure after everything but the sheath has been removed, the wall locating device is attached to the HD syringe assembly and the wall locator is inserted into the artery via the sheath.
  • A small opening near the distal tip of the wall locator communicates with blood in the artery and tells the operator that he or she is inside the artery.
  • 8-10 CC’s of blood is then withdrawn into the syringe containing the heparin removing mechanism and the wall locator and sheath are withdrawn until the blood stops dripping from the side port of the wall locator (indicating to the operator that he or she is outside the artery).
  • Once it is established that the small opening in the wall locator is outside the artery, the blood inside the syringe that has now had the heparin removed, is deployed over the arteriotomy and inside the tissue tract.
  • The sheath and HD are then removed and pressure is applied over the wound for 20 minutes. A robust seal will form in that period of time and the patient can then have their head elevated, bend their legs and generally make themselves comfortable for the next three hours or until they can successfully ambulate.

Content on this page requires a newer version of Adobe Flash Player.

Get Adobe Flash player

References:

  1. Turi, Zoltan MD, “Overview of vascular closure today, An Annual Review”, Endovascular Today, 2009;8:24-32.
  2. Dauerman, Harold MD FACC, Turi, Zoltan MD, “Overview of Vascular Closure” Endovascular Today, February 2008.
  3. Applegate, Robert MD FACC, Cohen, David MD, MSc., “Vascular Closure Devices: The Second Decade” American Journal of Cardiology, 2007; 50 (17) @Elsevier Science, Inc.
  4. Resnic,Frederick S. MD, “Editorial: The Case for Outpatient Coronary Intervention” Circulation 2007; 115:2248-2250.
  5. Jurgens, CP et al, “Patient tolerance and resource utilization associated with an arterial closure versus and external compression devices after percutaneous coronary intervention” Catheter Cardiovascular Intervention,200863 PP 166-17.0.
  6. Wong, S. Chiu MD “Perspectives on Vascular Closure Devices and the Latest Evidence” A presentation to the CIT Congress, March 2008, Beijing, China.

CloSys

Closys HD has addressed every concern voiced by non-VCD users:

Safety:

  • Nothing is “left behind”
  • A “fail-safe” mechanism is always present in the event of operator error or product failure.
  • No foreign materials are used eliminating a possible nidus for infection.
  • Only the pateint’s own deheparinized blood forms the sealing clot; the same seal that is formed when manual compression is used which has been proven to be safe for 40 years! Using the HD closes the arteriotomy in 20 minutes, however, as opposed to the 4-6 hours of pressure and immobilization required for manual compression closure

Ease-of-Use:

  • First generation devices require hundreds of cases to gain proficiency. Doctors and technicians learn to use the CloSys HD in 3-4 guided cases. HD is deployed using standard and intuitive cardiology manipulations

Cost:

  • The HD is not yet FDA approved and the cost to the customer has not yet been determined. The price is expected to be less than half of any currently approved closure device The CloSys HD offers all these advantages PLUS comparable Times-to-Hemostasis and Times-to-Ambulation.

CloSys Products are protected by the following issued patents and two patents pending all of which have been assigned to Closys Corporation:

U.S. Patent # 6,159,232 “Clotting cascade initiating apparatus and methods of use and methods of closing wounds” Nowakowski, K. December 12, 2000

U. S. Patent # 6,478,808 “Clotting Cascade initiating apparatus and methods of use” Nowakwoski, K. et al., November 12, 2002

U.S. Patent # 482,223 “Clotting Cascade initiating apparatus and methods of use” Nowakowski, K. et al. November 19, 2002

U.S. Patent # 6,989,022 Clotting cascade initiating apparatus and methods of use and methods of closing wounds”, Nowakowski, K . January 4, 2006