Medical Device Daily

Abbott (Abbott Park, Illinois) on Friday introduced a new specialty catheter designed to help physicians access areas of blockage in the coronary arteries and other vessels in the body that may be difficult to reach.

Known as the Asahi Tornus specialty catheter, the new stainless-steel device is engineered to deliver therapeutic, minimally invasive balloon catheters and stents to vessels blocked with dense fibrous fatty plaque – also known as chronic occlusions.

Bonnie Cheng, director of strategic marketing for coronary products at Abbott Vascular (Redwood City, Calif-ornia), told Medical Device Daily that the catheter is “certainly unique“ and that it is the only “specialty catheter“ of this type that's in the market.

The catheter was launched at Friday's session of the Third International Chronic Total Occlusion Summit in New York, and the product is available now in the U.S. There is no question there is demand for the device, Cheng said.

She said there has been a great deal of interest already in the product from physicians, noting that “we've gotten calls from around the world.“ She said Abbott is “incredibly thrilled“ about the product, because it is expected to help “very, very difficult-to-treat patients.“

Compared with areas of vessel narrowing, or what are commonly known as stenoses, chronic occlusions are typically longer and contain larger, denser masses of plaque, Abbott said.

Chronic occlusions generally are characterized by dense, fibrous tissue that is often partially calcified and difficult to penetrate with conventional interventional technology tools. The severity of a chronic occlusion is determined by the degree of vessel narrowing, the rate of blood flow through the narrowing, and the age of the occlusion, Abbott said.

Research has demonstrated that about 30% of patients with coronary artery disease have at least one chronic occlusion, the company said.

“The Tornus stainless-steel catheter gives us more support for accessing a type of occlusion that for decades has represented a major frustration for interventionalists,“ said interventional cardiologist Gregg Stone, MD, of the division of cardiology at Columbia University Medical Center and the Cardiovascular Research Foundation (both New York). “Chronic occlusions have proven so resistant to conventional interventional technology that we refer to them as the 'last frontier' in interventional therapy.“

Interventional therapy, also described as minimally invasive therapy, allows some patients with vessel disease to avoid surgery by undergoing treatment with balloon catheters or stents that are threaded to specific sites of vessel disease over therapeutic wires. Before a site of vessel blockage can be opened with a balloon or stent, it must be penetrated and crossed using a wire and support catheter. This often is referred to as crossing the lesion.

“If a lesion cannot be crossed, it cannot be treated with minimally invasive therapy, and a patient may have to be referred for open heart surgery,“ Stone said. “About 15% of the patients we see have this type of a blockage. The Tornus catheter allows us to cross dense areas of vessel blockage so they can be successfully dilated and stented.“

Support catheters are intended to provide additional assistance for physicians to access lesions with therapeutic wires. While most catheters are made of conventional plastic, the Tornus catheter is made of stainless steel to provide extra support during operator handling, Abbott said.

The Tornus design consists of “several hair-thin, stainless steel strands braided together to enhance flexibility and strength,“ along with a safety-release valve at the proximal end to indicate when the device has reached maximum rotation, and a “specialized tapered distal tip with a radio-opaque marker for optimal visualization in navigating difficult-to-access areas.“

The device is available in two sizes: 2.1 Fr for accessing lesions that are more difficult to navigate and 2.6 Fr for circumstances requiring more support to push through the lesion.

“Through our partnership with Asahi, we are pleased to offer physicians a new option for treating challenging lesions,“ said David Van Meter, general manager, coronary technologies, at Abbott Vascular. “The Tornus complements Abbott's broad line of Asahi guidewires, as well as our rapidly growing portfolio of devices for vascular interventionalists. These outstanding tools have earned high marks from the physicians who rely on them to deliver life-saving devices to patients with known areas of vessel disease.“

The Tornus is manufactured by Asahi Intecc (Aichi, Japan). Abbott has a licensing agreement with Asahi Intecc to distribute its guidewires in the U.S. and certain countries worldwide.

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