Mynx vascular closure device

The Mynx Vascular Closure Device is an extravascular vascular closure device (VCD) whose deployment system is designed to minimize the discomfort commonly associated with closing the small hole in the artery following catheterization procedure. The device is manufactured by AccessClosure, Inc., a medical device company located in Mountain View, California.

History

The Mynx received FDA Premarket Approval (PMA) in May, 2007.[1]

Device description

The device uses a soft, sponge-like sealant material to close the small hole in the femoral artery. The sealant works by rapidly absorbing blood and fluids around the puncture site, swelling in size and covering the hole. This seals the hole and stops the bleeding.

The sealant material consists of polyethylene glycol (PEG), a water-soluble, non-thrombogenic, conformable, bio-inert polymer. PEG has an established safety profile[2] and various forms of PEG are commonly used in a range of consumer and medical products including toothpaste, skin cream and lubricant eye drops.

Procedure

The device utilizes a gentle, extravascular deployment method, which avoids cinching or tugging of the artery by placing the sealant on the outside of the artery.

The procedure has been described in medical literature as causing little to no pain for the vast majority of patients.,[3][4]

The device utilizes the existing 5, 6 or 7 French procedural sheath, eliminating the need for a sheath exchange. This avoids potential tissue tract expansion, which can cause tissue trauma and oozing, a post-procedure hassle to the patient and nursing staff, often resulting in longer bed rest for the patient and potentially delaying ambulation and discharge.,[5][6]

As the sealant is placed on the outside of the artery, it is exposed to blood and subcutaneous fluids. The sealant rapidly expands, covering the hole in the artery and conforming to the tissue tract, producing a durable hemostasis.,[7][8]

This extravascular placement of the sealant avoids leaving behind an intravascular component, which can compromise blood flow and, in rare circumstances, embolize, requiring surgical repair.

The sealant fully dissolves within 30 days through hydrolysis.[9]

Sealant

The sealant avoids initiating platelet activation or an abnormal inflammatory response, and does not generate fibrous scar tissue. In addition, the porous characteristics of the sealant create a platform for natural clot formation and facilitate tissue healing.[10]

References

  1. ↑ US FDA/CDRH: New Device Approval – Mynx Vascular Closure System. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm Retrieved April 2, 2010
  2. ↑ D. Scheinert MD, et al. The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Vascular Closure: Initial Clinical Results for Mynx. Catheterization and Cardiovascular Interventions. 70:627-633 (2007)
  3. ↑ Gary M. Ansel MD, and Joseph M. Garasic MD. The Mynx Vascular Closure Device: Initial clinical experience using a novel approach to vascular closure. Endovascular Today. January 2008
  4. ↑ Charles L. Brown, III, MD, FACC, FACP. The Mynx Vascular Closure Device: The Piedmont Heart Institute Experience. Cath Lab Digest. February 2009
  5. ↑ Charles L. Brown, III, MD, FACC, FACP. The Mynx Vascular Closure Device: The Piedmont Heart Institute Experience. Cath Lab Digest. February 2009
  6. ↑ John B. Patterson, MD. Patient Comfort and Patient Satisfaction with the Mynx Vascular Closure Device: A Single-Center Evaluation. Cath Lab Digest. October 2009
  7. ↑ D. Scheinert MD, et al. The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Vascular Closure: Initial Clinical Results for Mynx. Catheterization and Cardiovascular Interventions. 70:627-633 (2007)
  8. ↑ Gary M. Ansel MD, and Joseph M. Garasic MD. The Mynx Vascular Closure Device: Initial clinical experience using a novel approach to vascular closure. Endovascular Today. January 2008
  9. ↑ D. Scheinert MD, et al. The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Vascular Closure: Initial Clinical Results for Mynx. Catheterization and Cardiovascular Interventions. 70:627-633 (2007)
  10. ↑ D. Scheinert MD, et al. The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Vascular Closure: Initial Clinical Results for Mynx. Catheterization and Cardiovascular Interventions. 70:627-633 (2007)
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