Mynx M5™ Offers Patients “Artery-Friendly” Closure Solution
Mountain View, Calif (June 22, 2009) – AccessClosure today announced the newest addition to the Mynx® Vascular Closure family, the Mynx M5. The M5 is now the only closure device on the market that can be delivered directly through a small 5 French (5F) cardiovascular sheath without enlarging the arterial hole or traumatizing the surrounding tissue in the process. This “artery-friendly” approach also benefits hospitals as the M5 eliminates the need for a sheath exchange, which saves procedure 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. 5F closure market is estimated at nearly $200M annually.
“Before the Mynx M5, existing closure devices required the physician to create a larger hole in the artery just to seal it in diagnostic cases,” explains Dr. Dharmesh Patel, M.D., F.A.C.C., a Diagnostic Cardiologist from Memphis Heart Clinic in Memphis, Tennessee. “The M5 is the first device that specifically addresses the primary clinical need for the 5F market, which is to reliably close the puncture site without enlarging it first. This is particularly useful in my practice allowing patients to ambulate quicker with greater safety and tolerability.”
The Mynx Vascular Closure Device was first approved by the FDA for 6F and 7F
cardiovascular procedures in May 2007. Since its full market release, the Mynx has been used in over 225,000 patients in over 700 hospitals nationwide. Of the Top 50 hospitals listed in US News & World Report’s “Best Hospitals: Heart & Heart Surgery,” over 75% have used the Mynx.
Like the original 6/7F 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.
Designed with the patient in mind, the Mynx offers a new solution to help minimize the discomfort commonly associated with vascular closure due to its unique deployment method and novel sealant material. Previous closure devices have used metal or animal-based implants to seal the arterial hole left after a cardiovascular procedure. By contrast, the Mynx uses a soft, bio-absorbable polymer material. This sealant material, polyethylene glycol (PEG), has been used safely for over a decade in a wide range of medical products such as gel caps and eye drops.
During the closure procedure, the sealant is placed gently over the arterial puncture area. The sponge-like sealant immediately expands three to four times its original size by rapidly absorbing blood around the puncture site, which immediately stops the bleeding and seals the artery. The sealant then dissolves naturally within 30 days, leaving nothing behind inside, or on top of, the artery.
About Vascular Closure
There are two methods of closing the femoral artery after cardiovascular procedures – manual compression and vascular closure devices. Manual compression entails up to 30 minutes of firm manual pressure applied directly to the access site, which is often painful for the patient, followed by many hours of bed rest in a hospital recovery room. Physicians frequently choose to use a vascular closure device (VCD) as an alternative to manual compression because it stops the bleeding more quickly, thereby allowing patients to leave the hospital earlier. However, despite the benefits of VCDs, many patients find that deployment of a VCD is extremely painful. The Mynx addresses this shortcoming by eliminating the tugging and cinching of the artery that occurs with other closure devices. The sealant is designed for gentle placement on top of the artery without the use of a suture or permanent metal implant.
Founded in 2002, AccessClosure, Inc. is a privately held medical device company pioneering innovative access site management products designed to provide a reliable, patientfriendly vascular closure experience. For more information visit our website at