Product Information

The Closys HD is designed to achieve the benefits of rapid closure while incorporating the well understood principles of manual compression. AS with manual compression, the patient's own depheparinized blood is used to close the arteriotomy. No foreign materials are used. Nothing is left behind. Using the CloSys system, the safety and reliability of manual compression is coupled with the benefit of shortened time-to-hemostasis and time-to-ambulation resulting in a closure system that speeds throughput in the catheterization laboratory and facilitates early discharge all the while making the patient's hospital experience more pleasant.

The CloSys system provides a quick, reliable, and safe natural closure using the same principles that are used for manual compression, but eliminates the hours spent waiting for anticoagulation status to return to normal. Nothing is left behind.

Watch the Video

See the CloSys HD in action.

How the HD works

1

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.

2

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.

3

8-10 CC's of blood is then withdrawn into the syringe containing the heparin removing mechanism and the wall locator and sheath are withdrawn until the blood stops dripping from the side port of the wall locator (indicating to the operator that he or she is outside the artery).

4

The sheath is re-advanced into the artery over the wall locator. The wall locator is removed and the patient is moved out of the catheterization laboratory with the sheath still in place…. Just as it is when manual compression is the closure method.

5

Once the patient is in the recovery area, the sheath is removed and twenty minutes of compression is held by any member of the sheath management team to achieve hemostasis. The patient stays flat in bed for 2 hours followed by 2 hours in a position of comfort. As is the case with other closure device systems, after 4 hours the patient is allowed to get up from bed (ambulate).

CloSys HD has Addressed Every Concern Voiced by Non-VCD Users

The CloSys HD was designed with quick reliable closure and safety first in mind

  • Uses the patient's own clotting blood to achieve closure immediately following intervention.
  • No foreign materials used.
  • Nothing is left behind.
  • No barrier to re-entry should it be required.

Easy to Use

  • Procedure with CloSys HD takes minimal time and is easy to use as evidenced by physicians and technical personnel trained in 3-4 guided cases

Cost Effective

  • It is expected, based upon current cost estimates, that the CloSys HD will be sold to end users at a significant discount to currently priced products.
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 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