Mynx Vascular Closure Device
   HOME

TheInfoList



OR:

The Mynx Vascular Closure Device is an
extravascular The blood vessels are the components of the circulatory system that transport blood throughout the human body. These vessels transport blood cells, nutrients, and oxygen to the tissues of the body. They also take waste and carbon dioxide away f ...
vascular closure device (VCD) whose deployment system is designed to minimize the discomfort commonly associated with closing the small hole in the
artery An artery (plural arteries) () is a blood vessel in humans and most animals that takes blood away from the heart to one or more parts of the body (tissues, lungs, brain etc.). Most arteries carry oxygenated blood; the two exceptions are the pu ...
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.


Device description

The device uses a soft, sponge-like
sealant Sealant is a substance used to block the passage of fluids through openings in materials, a type of mechanical seal. In building construction ''sealant'' is sometimes synonymous with '' caulking'' and also serve the purposes of blocking dust, so ...
material to close the small hole in the
femoral artery The femoral artery is a large artery in the thigh and the main arterial supply to the thigh and leg. The femoral artery gives off the deep femoral artery or profunda femoris artery and descends along the anteromedial part of the thigh in the f ...
. The sealant works by rapidly absorbing
blood Blood is a body fluid in the circulatory system of humans and other vertebrates that delivers necessary substances such as nutrients and oxygen to the cells, and transports metabolic waste products away from those same cells. Blood in the cir ...
and
fluids In physics, a fluid is a liquid, gas, or other material that continuously deforms (''flows'') under an applied shear stress, or external force. They have zero shear modulus, or, in simpler terms, are substances which cannot resist any she ...
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 Polyethylene glycol (PEG; ) is a polyether compound derived from petroleum with many applications, from industrial manufacturing to medicine. PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), depending on its molecular we ...
(PEG), a
water-soluble In chemistry, solubility is the ability of a substance, the solute, to form a solution with another substance, the solvent. Insolubility is the opposite property, the inability of the solute to form such a solution. The extent of the solub ...
, non-thrombogenic, conformable, bio-inert
polymer A polymer (; Greek '' poly-'', "many" + ''-mer'', "part") is a substance or material consisting of very large molecules called macromolecules, composed of many repeating subunits. Due to their broad spectrum of properties, both synthetic a ...
. PEG has an established safety profile and various forms of PEG are commonly used in a range of consumer and medical products including
toothpaste Toothpaste is a paste or gel dentifrice used with a toothbrush to clean and maintain the aesthetics and health of teeth. Toothpaste is used to promote oral hygiene: it is an abrasive that aids in removing dental plaque and food from the teeth, ...
, skin cream and lubricant
eye drop Eye drops or eyedrops are liquid drops applied directly to the surface of the eye usually in small amounts such as a single drop or a few drops. Eye drops usually contain saline to match the salinity of the eye. Drops containing only saline ...
s.


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.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 2008Charles L. Brown, III, MD, FACC, FACP. The Mynx Vascular Closure Device: The Piedmont Heart Institute Experience. Cath Lab Digest. February 2009 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.John B. Patterson, MD. Patient Comfort and Patient Satisfaction with the Mynx Vascular Closure Device: A Single-Center Evaluation. Cath Lab Digest. October 2009 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 In biology, hemostasis or haemostasis is a process to prevent and stop bleeding, meaning to keep blood within a damaged blood vessel (the opposite of hemostasis is hemorrhage). It is the first stage of wound healing. This involves coagulation, ...
. This extravascular placement of the sealant avoids leaving behind an
intravascular The blood vessels are the components of the circulatory system that transport blood throughout the human body. These vessels transport blood cells, nutrients, and oxygen to the tissues of the body. They also take waste and carbon dioxide away f ...
component, which can compromise blood flow and, in rare circumstances,
embolize An embolism is the lodging of an embolus, a blockage-causing piece of material, inside a blood vessel. The embolus may be a blood clot (thrombus), a fat globule (fat embolism), a bubble of air or other gas (gas embolism), amniotic fluid (amnio ...
, requiring surgical repair. The sealant fully dissolves within 30 days through
hydrolysis Hydrolysis (; ) is any chemical reaction in which a molecule of water breaks one or more chemical bonds. The term is used broadly for substitution, elimination, and solvation reactions in which water is the nucleophile. Biological hydrolys ...
.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)


Sealant

The sealant avoids initiating
platelet Platelets, also called thrombocytes (from Greek θρόμβος, "clot" and κύτος, "cell"), are a component of blood whose function (along with the coagulation factors) is to react to bleeding from blood vessel injury by clumping, thereby i ...
activation or an abnormal
inflammatory response Inflammation (from la, inflammatio) is part of the complex biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or irritants, and is a protective response involving immune cells, blood vessels, and molecu ...
, 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.


References

{{Reflist Implants (medicine) Interventional cardiology