AccessClosure Announces Distribution Agreement for Radial Compression Band

MOUNTAIN VIEW, Calif., Sept. 29 /PRNewswire/ -- AccessClosure, Inc., the market leader in extravascular closure devices, announced today an exclusive agreement with Benrikal Services to distribute the Bengal Radial Compression Band in the United States.  The Bengal, uniquely designed for transradial procedures, will join the Mynx™ Vascular Closure Device in AccessClosure's portfolio of products.
"We felt that it was crucial to offer a solution for our customers who use the radial approach," said Gregory D. Casciaro, President and CEO of AccessClosure.   "As a customer-focused company, we are striving to provide technologies for all approaches to access site management.  The Bengal complements the key features of the Mynx, both of which were designed to minimize impact on the artery, to offer clinical versatility, and to deliver a comfortable experience for the patient.  Including the Bengal in our closure portfolio allows AccessClosure to offer the same level of service and education to an even broader base of interventionalists."
The Bengal was designed in partnership with radial pioneer Olivier F. Bertrand, MD, PhD, FSCAI, an Interventional Cardiologist at the Quebec Heart-Lung Institute and Associate-Professor, Faculty of Medicine, at Laval University.  "I designed this device to address unmet needs in radial closure.  I wanted a simple tool that achieves quick and effective hemostasis, while protecting the ulnar nerve and providing a comfortable experience for the patient," said Dr. Bertrand.  "I also wanted to simplify post-operative care for my nursing staff: in my practice, the Bengal requires less monitoring time as it can be removed immediately at the end of the hemostasis period."
Vascular closure devices help to close an artery after cardiovascular procedures.  Interventional cardiologists may choose to access the coronary arteries through the radial artery in the wrist instead of the traditional approach using the groin.  Use of the radial technique has increased in the United States in the past several years, due in part to the evolution of the technologies that enable the procedure.  
The Bengal design offers a new approach to radial artery closure, combining a compression pad that delivers a unique pattern of targeted pressure with a soft polymer gel that ensures patient comfort while the band is on the wrist.  "Our Canadian customers appreciate the simplicity and ease-of-use of this band," said Guy Bélanger, President of Benrikal Services.  "As transradialists grow increasingly focused on avoiding radial occlusion after procedures, we have observed a natural inclination to a device that is very easy to adjust and optimize."

TCT: Weighing the risks and benefits of vascular closures

WASHINGTON, D.C.–Vascular closure devices can be successfully deployed and off-label devices not approved by the FDA can be used when they are evaluated on a patient-by-patient basis weighing the risks, benefits and cost, said D. Christopher Metzger, MD, of the Wellmont Holston Valley Medical Center in Kingsport, Tenn., during a presentation Sept. 24 at the 2010 Transcatheter Cardiovascular Therapeutics (TCT)  annual scientific meeting.
“The truth is, while we all try to use FDA-approved techniques and products, in the art of medicine, there come situations where there is no FDA approval out there to guide,” said Metzger. “In those cases, we have to individualize and use our clinical judgment and available evidence for the best interest of our patients.”
Often during peripheral artery intervention, a unique, alternative closure site is necessary when the usual route becomes blocked, Metzger said, “We often need popliteal artery access, radial access, large venous sheaths and the occasional puncture of the subclavian artery.”
With what Metzger called these “unique” accesses, he said that patients may benefit even more from closure devices due to the fact that often nurses are not familiar with pulling sheaths from these locations and the difficult nature of closure of some access sites, including the small popliteal artery.

Metzger explained that the antegrade popliteal artery or brachial arteries are harder to compress because of their smaller size. “If I open tiny arteries, I really don’t want you to sit there holding pressure for 15 to 20 minutes right after I finish it,” he said.
Metzger said that you must ensure that you are individualizing the risk/benefit ratio and costs prior to a procedure; use an angiogram to see whether or not you should use various devices; and individualize the closure devices to the particular patient artery.
Metzger offered that the Angio-Seal (St. Jude Medical) may not work best for smaller arteries like the brachial or popliteal arteries due to the size of the device left behind in the artery after closure. While he prefers using the Perclose ProGlide vascular closure system (Abbott Vascular), he said that you must be careful of the leading edge during peripheral work, particularly when maneuvering around a chronic total occlusion (CTO) or stent. He noted that the Perclose devices work best in the brachial arteries, popliteal arteries and sometimes even extravascular cases.
He also offered that the antegrade closure approaches are more complex compared with retrograde approaches because of the likelihood of puncturing the superficial femoral artery located in a higher position. However, Metzger noted that the Angio-Seal device may work best in these cases.
During popliteal artery access, Metzger said that a road-map approach is best  to puncture the artery in the right place. He and colleagues have used the procedure in almost 50 patient cases and have only had complications where a sheath needed replacement.
As for brachial access, he said that it is important to assess the artery and weigh the risks and benefit ratio of the procedure; however, he said that this procedure allows for the removal of larger sheaths while patients are fully anticoagulated, reducing the rates of thrombotic complications.
He noted that careful and accurate marking is most important when performing these closures so you ensure to not pinch a smaller artery closed and noted that the Perclose device may be best.
“Vascular closure devices can be used successfully in a large spectrum of  arterial and venous access sites off-label … the use of these devices has to be based on an individual assessment—the risks, benefits and costs, for each patient and their particular access site,” Metzger concluded.

Cardiac Catheterization - Closure market threatened as Trans Radial access gains US acceptance

Radial vs Femoral Access - Closure Device Market faces serious impact

While the US is slow to adopt this procedure it is somewhat inevitable that serious impact will be felt by companies involved in the vascular closure market.... The Body's Highway Interventional medicine, or catheter-based therapy, utilizes the body's circulatory system as a "highway" -- and avoids open surgery by threading catheters into arteries and delivering medicine and devices to the affected areas from the "inside-out". This highway can be accessed by several "on-ramps": the femoral artery in the groin, the radial artery in the wrist and the brachial artery in the elbow.

hollow catheter tip

The Femoral (Groin) Approach
When attempting to access the coronary arteries to clear a blockage with a balloon, or place a stent to hold the artery open, the most often used entry point to the circulatory system has been the femoral artery. A small puncture is made with a hollow needle, which then allows a long tube, called a catheter, to be threaded into the femoral artery, up and around the aorta and into the coronary arteries. This femoral approach, sometimes called the Judkins technique (afterDr. Melvin Judkins who invented it in the 1960's) is the standard way in which most catheter-based procedures are done in the U.S.

However, there are some limitations to the femoral approach. The femoral or nearby arteries may be diseased and will not allow a catheter to pass easily. Sometimes a patient is overweight or obese, and the femoral artery is buried deep underneath the fatty tissue, making it hard to access, and then equally hard to compress after the procedure -- a necessary step in stopping the bleeding. In some cases, bleeding that is not immediately visible to the eye can occur in a backwards fashion into the body cavity -- this can be seen as a discoloration, like a bruise, that expands and must be treated. The possibility of involvement of the femoral nerve also exists. These types of complications are small in number, often quoted at 3%.

Invention of the Radial Technique
In the late 1980's, a French-Canadian physician, Dr. Lucien Campeau, started using the right radial artery, which is located in the wrist, as an entry point for diagnostic catheterizations. While the radial artery is slightly smaller than the femoral, it is still large enough to allow most catheters to traverse the distance to the coronary anatomy. In fact the radial artery was initially harvested and used in coronary artery bypass grafts.

By 1992 a group in Amsterdam, headed by Dr. Ferdinand Kiemeneij, had begun exploring ways to use the radial artery for interventional procedures, such as delivering balloons and stents. They were somewhat limited by the early equipment, but as catheters and stents became lower profile, thinner and easier to manipulate, the ability of physicians to use the radial artery increased. Most devices today can be delivered successfully using the radial artery.

Advantages of the Radial Approach
Most of the disadvantages of the femoral technique are nonexistent in the radial, also called the transradial approach. Even in obese patients, the radial artery is close to the skin surface, making the initial needle puncture simple and straight-forward. For the same reason, when the procedure has been completed, a short compression of the radial artery can stop the bleeding (achieve hemostasis) -- even when the patient has been aggressively anticoagulated with medicines to keep blood clots from forming, more and more common in the modern cath lab. Should any bleeding occur, it can be seen immediately. Finally, unlike the proximity of the femoral artery to the femoral nerve, the radial artery is not close to a major nerve, so the likelihood of "nicking" a nerve during the procedure is very low.

While complications are less common with the radial technique, the advantage experienced by all radial patients is that there is no longer any need to lie flat and still for 4-6 hours, or to experience what is sometimes a painful manual compression of the artery to curb the bleeding. Patients leave the catheterization lab and are able to sit up and walk almost immediately. Because of the simpler healing process for the arterial puncture in the wrist, certain patients may also be discharged home without having to spend the night.

The progress in the treatment of coronary artery disease has evolved to the point that when you compare heart bypass surgery from two decades ago with stenting done today via the transradial approach, what was a 4 hour major open heart operation, with general anesthesia, a week or more in the hospital and months of recovery, can now in some cases be performed as an outpatient procedure.

Is the Radial Approach for Everyone? There are a few prerequisites for patients to be a candidate for the transradial approach. The first is confirmation of a dual, or "protected", blood supply to the hand. The radial artery loops around the hand and joins the ulnar artery. Both arteries supply blood to the hand and fingers. It is precisely this dual blood supply that makes the radial technique safe. Should the radial artery close up (a complication seen in a small percentage of cases) the clinical result tends to be benign, because the ulnar artery continues to function. The first step a cardiologist takes in deciding on the radial approach is an Allen test to assess that both radial and ulnar arteries are functioning normally -- a simple test that can be done by compressing the arteries by hand at bedside or in the doctor's office. If they are not normal, then the femoral approach is preferred. Some other contraindications exist, such as the need to use larger devices during the angioplasty, pre-existing bypass grafts in certain areas or tortuous vessels that may prevent the catheter from navigating to the coronaries from the arm. About 30-40% of patients are not candidates for radial access.

While the complication rate with the radial approach is extremely low, there is always some risk with any medical procedure. It is important for patients to discuss the risks and benefits of the femoral vs. radial approaches, as these can vary for each individual.

Limited Utilization in the United States
The more frequent reason that patients are not offered the radial approach is that only a relatively small percentage of interventional cardiologists in the U.S. are trained in the technique. Parts of Europe and Japan do 40% or more of their cases using the radial artery, but in the U.S. estimates are in the low single digits -- although those U.S. cardiologists and radiologists who have learned the radial technique tend to use it for many, if not most, of their patients.

The reasons for this low penetration are several: lack of economic incentive due to the reimbursement structure, lack of patient awareness that this alternative exists, and lack of trained cardiologists. The situation, however, is changing. More and more practices are beginning to see the advantages in lower complication rates, increased patient satisfaction and even cost-savings (complications can be expensive to manage).

The femoral approach has been the gold standard for many years. Moving to the newer radial technique requires specialized training and advanced skills. Training opportunities are increasing as computer simulation models are being developed and a number of hospitals, both in and outside of the U.S. are now offering programs and mentorships. Current signs point to the increasing use of the radial technique in the U.S.

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Cost-Effectiveness of the Radial versus Femoral Artery Approach to Diagnostic Cardiac Catheterization

Study: Terumo TR Band™ Hemostasis Device Reduces Radial Artery Occlusion by 56%

A new study, conducted by Dr. Samir B. Pancholy of Mercy Hospital in Scranton, Pennsylvania, shows that the concept of "guided compression" in transradial procedures can reduce radial artery occlusion by 56%, especially when facilitated by the use of the TR Band™ Hemostasis Device.
While infrequent (in the single digits), radial artery occlusion is a discouraging complication of radial artery access.
Although it is usually benign for the patient, it precludes future radial access. For example, if the radial artery occludes after a diagnostic catheterization, any subsequent PCI procedures must be done via the femoral artery.

But there are a number of methods for achieving hemostasis in a radial procedure. Pancholy looked at data from his own lab and saw that patients on whom he had used the TR Band, as opposed to the commonly-used HemoBand, had significantly lower rates of radial artery occlusion. So Dr. Pancholy devised a randomized clinical study to test the efficacy of the TR Band in preventing radial artery occlusion.
500 consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. 250 consecutive patients received hemostasis by application of HemoBand (Group I) and the next 250 patients received hemostasis using the inflatable TR band (Group II). Radial artery patency was studied the time of application of the hemostasis device, at 30 minutes, 60 minutes and at 24 hour and 30 days using Barbeau’s test.
The results were that 28 patients in Group I (11.2%), developed evidence of early occlusion (at 24 h), compared to 11 patients (4.4%) in Group II (P<0.005).>