Healthcare Industry News: vascular access
News Release - January 31, 2011
Boston Scientific Announces FDA Approval of Renegade(R) HI-FLO Fathom(R) Pre-Loaded SystemNew system integrates market-leading Renegade HI-FLO Microcatheter with high-torque Fathom-16 Steerable Guidewire for peripheral embolization procedures
NATICK, Mass., Jan. 31, 2011 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE:BSX ) today announced that the U.S. Food and Drug Administration (FDA) has approved its Renegade® HI-FLO™ Fathom® Pre-Loaded System for selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. The system will primarily be used by interventional radiologists for minimally invasive procedures to treat uterine fibroids and liver cancer. The Company said it plans to launch the product immediately in the United States.
The Renegade HI-FLO Fathom Pre-Loaded System combines the turn-for-turn torque response, flexibility and high visibility of the Fathom-16 Steerable Guidewire with the clinically proven performance of the Renegade HI-FLO Microcatheter, pre-loaded in a single convenient platform. The system will be available in eight configurations to suit a broad range of peripheral embolization procedures.
"The excellent deliverability, torque transmission and flow capacity of the Renegade HI-FLO Fathom Pre-Loaded System provides physicians with the performance they need to efficiently access tortuous vessels across many types of interventional oncology procedures," said Jeff Geschwind, M.D., Professor of Radiology, Surgery and Oncology, and Director of Vascular and Interventional Radiology at the Johns Hopkins University School of Medicine. "Having the Fathom-16 Guidewire pre-loaded in the Renegade HI-FLO Microcatheter will reduce my procedural preparation time and the number of devices that my staff must manage."
The Renegade HI-FLO Fathom Pre-Loaded System complements Boston Scientific's extensive portfolio of minimally invasive access and embolization products to provide physicians with a range of diagnostic and treatment options for uterine fibroids, liver cancer and other conditions requiring interventional procedures.
"Adding the pre-loaded system to our product offerings demonstrates Boston Scientific's commitment to providing a comprehensive suite of less-invasive solutions for interventional radiologists and their patients," said Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Endovascular Unit. "We will continue to bring additional technologies to market that advance the various therapies performed by specialists in vascular and interventional radiology."
About Uterine Fibroids
Uterine fibroids are non-cancerous growths that develop in the muscular wall of the uterus or cervix, and are estimated to occur in up to 40 percent of women of child-bearing age. Although most uterine fibroids are asymptomatic, some can cause heavy and painful menstrual bleeding, pelvic pressure and frequent urination. Treatment options include medication, hysterectomy, myomectomy (surgical removal of fibroids from the uterus) and uterine artery embolization (UAE). In UAE, a physician uses minimally invasive techniques under local anesthesia to access and occlude both uterine arteries, reducing or eliminating blood flow to the fibroid. Uterine fibroids are the most common benign tumors in women and are the most frequent indication for hysterectomy among pre-menopausal women.
About Liver Cancer
Liver cancer is one of the most commonly diagnosed forms of cancer worldwide, with more than 800,000 patients diagnosed annually. The average life expectancy of many patients with liver cancer is less than one year. Treatment options include surgical resection, chemotherapy, radiation, tumor ablation, and several minimally invasive options, including transarterial chemoembolization (TACE) and radioembolization. In the minimally invasive options, a physician will establish endovascular access to the hepatic artery under local anesthesia to deliver one of several acute therapies.
About Boston Scientific
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 27A of the Securities Act of 1933 and 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 new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings. 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.
Source: Boston Scientific
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