A Medical Device Daily
AccessClosure's (Mountain View, California) plans to gain ground in the manual compression market have come to fruition with the FDA approval of the M5, an addition to the Mynx Vascular Closure family.
The company, which was formed in 2002, is touting the device as the only one on the market that can be delivered through a small 5 Fr cardiovascular sheath without enlarging the arterial hole or traumatizing the surrounding tissue in the process.
The approach is being called artery friendly and is said to benefit hospitals, as the M5 stops the need for a sheath exchange, which saves time and expense.
Typically, procedural sheaths that are 5F in size (a common unit of measurement for cardiovascular devices) are used in diagnostic coronary and peripheral catheterizations. Several million diagnostic procedures are performed each year in the U.S. alone. The U.S. 5 Fr closure market is estimated at nearly $200 million annually.
The Mynx Vascular Closure Device was first approved by the FDA for 6 Fr and 7 Fr cardiovascular procedures in May 2007. Since its full market release, the Mynx has been used in more than 225,000 patients in some 700 hospitals nationwide.
Like the original 6 Fr/7 Fr Mynx device, the Mynx M5 offers patients the same important benefit – a comfortable closure experience. Many patients report that closing their artery was the most painful part of their cardiovascular procedure.
The device achieves femoral artery hemostasis via extravascular delivery of polyethylene glycol (PEG), a biomaterial commonly used in medical devices and pharmaceutical products.
Here's how it works:
The water-soluable PEG mix sealant is delivered to the targeted area via a 6 Fr or 7 Fr procedural sheath. Temporary hemostasis is achieved by introducing an inter-arterial balloon, followed immediately by the mix sealant.
The non-thrombogenic sealant then instantly absorbs blood and subcutaneous fluid, rapidly expanding up to three to four times its original size inside the tissue tract and producing a durable hemostasis. The sealant dissolves within about 30 days, leaving nothing behind but a healed artery.