Boston Scientific Announces FDA Approval Of Renegade(R) HI-FLO™ Fathom(R) Pre-Loaded System

Boston Scientific Corporation (NYSE: BSX) 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.


Source:

Boston Scientific