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Boston Scientific Expands PolarCath® Peripheral Dilatation System With New Balloon Sizes

Mon, 06/21/2010 - 4:36am
Boston Scientific

NATICK, Mass., June 21 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that 22 new balloon sizes have been added to the PolarCath® Peripheral Dilatation System, including balloon lengths of 120 and 150 mm.  The PolarCath System is used to restore blood flow in patients with critical limb ischemia (severe blockages in the arteries below the knee) and blockages in the femoral and popliteal (behind the knee) arteries.  Both conditions result from peripheral artery disease.  

Peripheral artery disease is a circulatory disorder that affects approximately 27 million people in North America and Europe.  It results from a build-up of plaque in one or more arteries of the legs.  As the disease progresses, accumulation of plaque may significantly reduce blood flow through the arteries, resulting in pain and increasing disability.  In severe cases, amputation may be the only treatment option.  Angioplasty, bypass graft surgery and thrombolytic (anti-clotting) therapy have traditionally been used to prevent further disability and/or amputation.

The new PolarCath 120 and 150 mm balloons are available in both 0.014-inch and 0.035-inch guidewire-compatible platforms.  The PolarCath System also offers balloon lengths of 20, 40, 60, 80 and 100 mm.

"The expanded portfolio of PolarCath balloons will enable interventionalists to address longer lesions in the femoral and subfemoral arteries, often more efficiently than using several shorter balloons," said Tony S. Das, M.D., Director of Peripheral Vascular Interventions at the Presbyterian Heart Institute in Dallas.  "The PolarCath System also offers the potential benefits of CryoPlasty® Therapy for these complex lesions."

CryoPlasty Therapy is a novel form of balloon angioplasty -- delivered by the PolarCath System -- that cools the inside of occluded arteries in the legs while opening the blockages.  This technology uses nitrous oxide to fill an angioplasty balloon within a blocked artery, cooling the balloon's surface to -10 degrees C.  As it is inflated, the cold surface of the balloon cools and dilates the vascular lesion.  In the BTK CHILL study of patients with blockages in the arteries below the knee, CryoPlasty Therapy resulted in a high rate of limb salvage in patients with critical limb ischemia.  Boston Scientific is the only company to offer CryoPlasty Therapy.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.  

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding clinical trials, product performance, competitive offerings, procedural volume, overall market size and our market position.   If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.  

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

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