The new device transitional pass-through code (C1748) may be used to bill for EXALT Model D when it is used in treatment of Medicare beneficiaries in the hospital outpatient setting starting
The EXALT™ Model D Single-Use Duodenoscope is the world's first and only single-use, flexible duodenoscope currently cleared by the
Notably, the FDA has recommended that providers transition to duodenoscopes with disposable components or fully disposable devices, when they are available.2
The FDA granted EXALT Model D its Breakthrough Devices Designation through a program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Breakthrough Device Designation provides patients more timely access to novel medical devices such as Exalt Model D.
"The approval of this new payment category in the outpatient setting will help ensure healthcare providers have access to EXALT Model D at a time when there is heightened awareness of the need to eliminate infection risk for patients, physicians, and hospital staff. With EXALT Model D, physicians can use a new, sterile duodenoscope for every procedure," said
The EXALT™ Model D Single-Use Duodenoscope received FDA clearance in
Please visit www.bostonscientific.com/EXALT for more information about the EXALT Model D Single-Use Duodenoscope.
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 our product launches 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 economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; the closing and integration of acquisitions; 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
(508) 683-4797 (Office)
- Internal Estimate
United States Food and Drug Administrationwebsite: " The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication" April 10, 2020
View original content to download multimedia:http://www.prnewswire.com/news-releases/boston-scientific-receives-medicare-transitional-pass-through-payment-for-the-exalt-model-d-single-use-duodenoscope-301071712.html