Thursday, April 28, 2022
Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the EMBOLD™ Fibered Detachable Coil, which is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The first procedure using the device was performed this week at the University of Alabama at Birmingham.
The newest addition to the Boston Scientific interventional oncology portfolio, the EMBOLD Fibered Coil was designed for use in a variety of embolization procedures, a minimally invasive treatment intended to block one or more blood vessels to obstruct or reduce blood flow. Occlusion in this manner is a technique used to stop hemorrhaging, prevent aneurysm ruptures, reduce the size of certain tumors and treat a variety of venous abnormalities.
“When performing an embolization procedure, it is essential to have a device that is easy to use from start to finish,” said Dr. Theresa M. Caridi, director, Division of Vascular and Interventional Radiology from the Heersink School of Medicine at the University of Alabama at Birmingham, and the first physician to treat a patient with the EMBOLD Fibered Detachable Coil.[i] “The multi-catheter compatibility of the EMBOLD Fibered Coil provides physicians the flexibility of catheter choice and helps reduce the number of potential device exchanges, which may improve procedure efficiency and enable better patient outcomes.”
In addition to the multi-catheter compatibility of the EMBOLD Fibered Coil, the device also features a nitinol delivery system that prevents kinks from forming in the device during the procedure – features intended to reduce treatment complications. These design attributes may also reduce preparation and procedure times by limiting the amount of equipment and additional products required to complete treatment, which may reduce the overall cost of the procedure.
“The EMBOLD Fibered Coil was developed to address physician feedback about the need to simplify the embolization process,” said Peter Pattison, president, Interventional Oncology, Peripheral Interventions, Boston Scientific. “With the introduction of this coil, physicians now have a tool that streamlines the embolization procedure, and we continue to explore innovative solutions that meet physician needs so they can provide the highest standard of care to their patients.”
A full commercial launch of the device will begin in the U.S. in the coming weeks. For more information, please visit the EMBOLD™ Fibered Detachable Coil page on the Boston Scientific website.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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,” “may”, “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 our business plans and product performance and impact. 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 U.S. and global economic, political, competitive, reimbursement and regulatory conditions; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; and future business decisions made by us and our competitors. New risks and uncertainties may arise from time to time and are difficult to predict, including those that have emerged or have increased in significance or likelihood as a result of the COVID-19 pandemic. 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.