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.
The Mynx received FDA Premarket Approval (PMA) in May 2007. [1]
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.
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. [4] [5]
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. [2] [3]
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. [2]
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. [2]
A central venous catheter (CVC), also known as a central line(c-line), central venous line, or central venous access catheter, is a catheter placed into a large vein. It is a form of venous access. Placement of larger catheters in more centrally located veins is often needed in critically ill patients, or in those requiring prolonged intravenous therapies, for more reliable vascular access. These catheters are commonly placed in veins in the neck, chest, groin, or through veins in the arms.
In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic procedures. The process of inserting a catheter is catheterization.
Angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. Modern angiography is performed by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy.
Interventional radiology (IR) is a medical specialty that performs various minimally-invasive procedures using medical imaging guidance, such as x-ray fluoroscopy, computed tomography, magnetic resonance imaging, or ultrasound. IR performs both diagnostic and therapeutic procedures through very small incisions or body orifices. Diagnostic IR procedures are those intended to help make a diagnosis or guide further medical treatment, and include image-guided biopsy of a tumor or injection of an imaging contrast agent into a hollow structure, such as a blood vessel or a duct. By contrast, therapeutic IR procedures provide direct treatment—they include catheter-based medicine delivery, medical device placement, and angioplasty of narrowed structures.
In surgery, a percutaneous procedure is any medical procedure or method where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using an "open" approach where inner organs or tissue are exposed.
A coronary catheterization is a minimally invasive procedure to access the coronary circulation and blood filled chambers of the heart using a catheter. It is performed for both diagnostic and interventional (treatment) purposes.
Interventional cardiology is a branch of cardiology that deals specifically with the catheter based treatment of structural heart diseases. Andreas Gruentzig is considered the father of interventional cardiology after the development of angioplasty by interventional radiologist Charles Dotter.
Cardiac catheterization is the insertion of a catheter into a chamber or vessel of the heart. This is done both for diagnostic and interventional purposes.
Transcatheter arterial chemoembolization (TACE) is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply. Small embolic particles coated with chemotherapeutic drugs are injected selectively through a catheter into an artery directly supplying the tumor. These particles both block the blood supply and induce cytotoxicity, attacking the tumor in several ways.
Uterine artery embolization is a procedure in which an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the uterine body. The procedure is done for the treatment of uterine fibroids and adenomyosis. This minimally invasive procedure is commonly used in the treatment of uterine fibroids and is also called uterine fibroid embolization.
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat narrowing of the coronary arteries of the heart found in coronary artery disease. The process involves combining coronary angioplasty with stenting, which is the insertion of a permanent wire-meshed tube that is either drug eluting (DES) or composed of bare metal (BMS). The stent delivery balloon from the angioplasty catheter is inflated with media to force contact between the struts of the stent and the vessel wall, thus widening the blood vessel diameter. After accessing the blood stream through the femoral or radial artery, the procedure uses coronary catheterization to visualise the blood vessels on X-ray imaging. After this, an interventional cardiologist can perform a coronary angioplasty, using a balloon catheter in which a deflated balloon is advanced into the obstructed artery and inflated to relieve the narrowing; certain devices such as stents can be deployed to keep the blood vessel open. Various other procedures can also be performed.
Lutembacher's syndrome is a very rare form of congenital heart disease that affects one of the chambers of the heart as well as a valve. It is commonly known as both congenital atrial septal defect (ASD) and acquired mitral stenosis (MS). Congenital atrial septal defect refers to a hole being in the septum or wall that separates the two atria; this condition is usually seen in fetuses and infants. Mitral stenosis refers to mitral valve leaflets sticking to each other making the opening for blood to pass from the atrium to the ventricles very small. With the valve being so small, blood has difficulty passing from the left atrium into the left ventricle. Septal defects that may occur with Lutembacher's syndrome include: Ostium primum atrial septal defect or ostium secundum which is more prevalent.
A coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease. It is used in a procedure called percutaneous coronary intervention (PCI). Coronary stents are now used in more than 90% of PCI procedures. Stents reduce angina and have been shown to improve survivability and decrease adverse events in an acute myocardial infarction.
In medicine, a port is a small medical appliance that is installed beneath the skin. A catheter connects the port to a vein. Under the skin, the port has a septum through which drugs can be injected and blood samples can be drawn many times, usually with less discomfort for the patient than a more typical "needle stick".
Atrial septostomy is a surgical procedure in which a small hole is created between the upper two chambers of the heart, the atria. This procedure is primarily used to palliate dextro-Transposition of the great arteries or d-TGA, a life-threatening cyanotic congenital heart defect seen in infants. It is performed prior to an arterial switch operation. Atrial septostomy has also seen limited use as a surgical treatment for pulmonary hypertension. The first atrial septostomy was developed by Vivien Thomas in a canine model and performed in humans by Alfred Blalock. The Rashkind balloon procedure, a common atrial septostomy technique, was developed in 1966 by American cardiologist William Rashkind at the Children's Hospital of Philadelphia.
Dr. Thomas J. "Tom" Fogarty is an American surgeon and medical device inventor. He is best known for the invention of the embolectomy catheter, which revolutionized the treatment of blood clots (embolus).
A cardiac electrophysiology study is a minimally invasive procedure using catheters introduced through a vein or artery to record electrical activity from within the heart. This electrical activity is recorded when the heart is in a normal rhythm to assess the conduction system of the heart and to look for additional electrical connections, and during any abnormal heart rhythms that can be induced. EP studies are used to investigate the cause, location of origin, and best treatment for various abnormal heart rhythms, and are often followed by a catheter ablation during the same procedure.
Vascular closure devices (VCDs) are medical devices used to achieve hemostasis of the small hole in the artery after a cardiovascular procedure of endovascular surgery requiring a catheterization.
ICU Medical, Inc. is a San Clemente, California-based company with global operations that develops, manufactures, and sells medical technologies used in vascular therapy, oncology, and critical care applications.
Carbon dioxide angiography is a diagnostic radiographic technique in which a carbon dioxide (CO2) based contrast medium is used - unlike traditional angiography where the contrast medium normally used is iodine based – to see and study the body vessels. Since CO2 is a non-radio-opaque contrast medium, angiographic procedures need to be performed in subtraction angiography (DSA).