LONDON, November 8, 2022 – Boston Scientific Corporation (NYSE: BSX) today announced the European launch of the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, a long-term diagnostic device inserted under the skin of patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.
The LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrythmias before an alert is sent to clinicians. The algorithm can be programmed remotely to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes, and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded.
In addition, this technology also has the potential to support patient follow up of electrophysiology procedures through remote monitoring, which could play an important role in supporting the efficiency of medical teams. Remote patient monitoring can help clinicians prioritise care when hospital teams are under pressure by providing guidance for triaging each patient.
“We had the opportunity to be one of the first in the UK to implant the LUX-Dx™ ICM. Signals seen so far at implant have been providing great sensing and amplitude of P waves as well as fibrillation waves. Patients have been happy and confident with the ease of setup and use of their patient phone.” said Lydia Bradley, CRM Service Lead Physiologist & ACP at the Hospital is Royal Wolverhampton NHS Trust, England. “Ease of use, clarity of the information and intuitive platform are invaluable in helping us make prompt decisions.”
Following implantation of the LUX-Dx ICM System, patients are provided with a mobile device preloaded with the MyLUX™ app which connects via Bluetooth® to their ICM device. The app transmits device data daily, or as needed, to the LATITUDE Clarity™ Data Management System, giving physicians and care teams timely access to vital information.
“We are excited to expand our reach into the cardiac diagnostic field with the LUX-Dx ICM System,” said Angelo De Rosa, vice president and general manager EMEA, Rhythm Management, Boston Scientific. “Signal quality, dual-stage algorithm and remote programming will further unlock the potential of remote patient monitoring technology in Europe and reinforce the therapy offerings we can provide to physicians, from diagnosis to treatment.”
The LUX-Dx ICM System has CE Mark in Europe and U.S. Food and Drug Administration 510(k) clearance. For more information on the LUX-Dx ICM System, please click here.
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.eu and connect on Twitter and Facebook and LinkedIn.
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 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 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.
Media Relations EMEA
+44 7772 404018 email@example.com
001 (508) 683-5670 (office) BSXInvestorRelations@bsci.com