Medical Device Daily

Cook's (Bloomington, Indiana) new Miraflex microcather, designed especially to complement the company's existing embolization products, may just be the interventionalist's new best friend.

The microcather can essentially "navigate" all over the body — literally from head to toe — with the indicated use being in small vessels or in "super-selective" anatomy for diagnostics and interventional procedures, including neurological, peripheral or coronary vasculature.

The company last week reported FDA clearance of the device.

"As you might imagine, as technology has evolved, the technology for the major vessels — the aorta, the femoral artery — have been available for a number of years," Rob Lyles, global leader of Cook's peripheral intervention division, told Medical Device Daily. "And now physicians are getting good enough and demanding enough that they're getting farther into the periphery, if you will, into the visceral system within your organs, getting very far down into the leg, even into the toe."

The microcatheter also can be used in conjunction with Cook's other microcoil products to embolize vessels in the tongue, i.e., "vessels wherever they are and being able to apply a therapeutic . . . ," Lyles said.

The FDA cleared the device for market last year.

An embolization procedure stops blood flow to malformed or otherwise problematic blood vessels within a patient. Typically, embolic material is delivered precisely within the vessel to stop the bleeding from a damaged artery or blood flow to an aneurysm.

The embolic devices are delivered through the catheter with the tip lying in or near the vessel to be occluded. Such embolization procedures can be used to control bleeding in an injury or trauma situation, as well as used to stop blood flow to a tumor, which ultimately kills the tumor.

According to Andrew Conder, senior global product manager at Cook, the "premise" behind any microcather is to be able to "give more pinpoint therapy, more targeted therapy . . ." in order to cause less necrosis, or killing of tissue. As physicians go farther into the body with catheters and treatment, the downside is that there may be more injury to tissue.

Conder said it's vital in a situation such as embolization in the liver to be "very, very selective" of the embolic used.

The MiraFlex catheter, which is .021 inches at its inner diameter, is designed for optimal coil delivery when it is used in combination with Cook's MicroNester and Tornado Microcoils, which are used to create occlusions.

The catheter is used with a needle guidewire catheter technique to enter the body, which involves going into an artery, such as the femoral artery in the groin area, where a needle is inserted. A wire is then inserted into the needle, over which a catheter can be inserted to follow the direction of the wire as it moves through the body. At that point, the microcoils would be inserted through the catheter to create an occlusion.

Because of its potential to journey long distances through the body, some catheters are quite long, Lyles said. Also because of the distance a microcather such as MiraFlex may need to travel, it is required to have certain characteristics, such as "pushability" and "kink-resistance."

Cook said that MiraFlex has a braided construction along the entire length of the catheter shaft to the radiopaque band. That helps to improve torque response and allows for "quicker vessel selection," it said. The braided design also contributes to the flexibility of the catheter — much the way there is braiding in a garden hose, Conder said — that gives the MiraFlex the ability to carry higher flow rates.

Each microcatheter is hydrophilic-coated, which Cook said reduces surface friction. The body of microcather is "stout" to offer "improved pushability and control" and leads to a "soft, flexible distal tip."

"Miraflex has further added to my collection of resources for treatment of post traumatic embolizations all the way to complex posterior epistaxis embolizations," said Awais Siddique, MD, chief endovascular interventional radiologist at the Aurora Sheboygan Medical Center, (Sheboygan, Wisconsin). "The catheter's flexible braided design, along with its unique five transitional zones, gives it great pushability and the highly visible tip design is needed for the most challenging and tortuous anatomy. Miraflex has one of the most durable hub designs which, in my opinion, makes it a much sturdier catheter."

Miraflex is approved for sale in the U.S., Australia, Canada, Singapore, India, Argentina, Brazil, Chile, Costa Rica, and El Salvador.