FDA Approves Data Streaming from the Impella Console, Setting the Stage for Artificial Intelligence Algorithms to Further Improve Patient Outcomes
The United States Food and Drug Administration (FDA) has approved one-way digital data streaming during patient support from Abiomed's (NASDAQ: ABMD) Automated Impella Controller (AIC), the external console used with Impella heart pumps. The data streaming capability is facilitated through the Impella Connect interface, a HIPAA-compliant, cloud-based remote monitoring platform that is currently installed at more than 200 hospitals. The approval means console data could be streamed live via Impella Connect to a secure server where artificial intelligence (AI) could provide predictive clinical information to the patient’s physician.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200716005318/en/
Figure 1 (Photo: Business Wire)
As an example of how this technology might be used in future clinical practice, Abiomed has already trained an AI algorithm to predict the next five minutes of a patient’s arterial pressure based only on the prior five minutes of console data. (see Figure 1) Abiomed has also developed AI algorithms to predict other parameters, such as stroke volume, left ventricular pressure and cardiac output. The AI algorithms are not yet cleared or approved for patient use. Once fully developed, they will be submitted for regulatory review.
Predictive analytics are possible by integrating Impella clinical study data with Impella console data from thousands of cases and training artificial intelligence networks on the co-registered data. AI networks could then receive and analyze console data in real-time and send patient-specific predictions to that patient’s medical provider. (see Figure 2)
“Artificial intelligence networks, properly trained using large volumes of streaming data, can be powerful tools to aid in clinical decision-making,” said Chuck Simonton, MD, Abiomed’s chief medical officer. “One day, using artificial intelligence, physicians may be able to confidently predict a patient’s future hemodynamics. That would make clinical decision-making more efficient and improve patient outcomes.”
Abiomed is also studying artificial intelligence to make more holistic predictions, such as the probability a patient will recover his or her native heart function. This information could help medical providers determine if an alternative course of action is needed.
More information on the future direction of Impella technology, including the application of artificial intelligence, is available in this online presentation.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to reopen blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP® is U.S. FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery. The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP has been authorized for the above emergency use by FDA under an EUA and has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to 5 days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with SmartAssist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit www.impella.com.
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella 5.5, Impella LD, Impella CP, Impella RP, SmartAssist and Impella Connect are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella BTR, Impella ECP, CVAD Study and STEMI DTU Study are pending trademarks of Abiomed, Inc.
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic, development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and the filings subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
International AI Art Competition Enters Final Round30.9.2020 18:16:00 CEST | Press release
Ten finalists have been announced for AI Artathon, the first ever international AI Art competition held in Saudi Arabia. The finalists were revealed during a livestream event to showcase artworks created by the competitors using artificial intelligence tools and techniques. The three winning teams will be announced at the Global AI Summit on 22nd October, where they will share a prize of US$133,000. The AI Artathon is an initiative of the Global AI Summit, to highlight the creative potential of humans and machines working together to create innovative artworks. Twenty teams made up of artists, graphic designers, AI experts and programmers, competed in this stage of the competition, after qualifying during a hackathon held in Riyadh in January. Over 2,000 people from over 50 countries applied to participate in the hackathon, with 300 selected for the three-day event, where teams were formed to develop initial AI art concepts. Twenty teams were selected to take part in a bootcamp, where
VALBIOTIS Publishes Its 2020 Half-Year Results and Provides an Update on Its Global Strategic Partnership with Nestlé Health Science, its strong Financial Visibility and the Promising Advances in Its Pipeline30.9.2020 17:40:00 CEST | Press release
Regulatory News: VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / eligible for the PEA/SME), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces its results for the first half of 2020 and provides an update on developments since the beginning of the year. Sébastien PELTIER, CEO of VALBIOTIS, commented: "Events in the first half of 2020 have transformed our outlook and helped further boost our international recognition. With the signature of the development and marketing partnership for TOTUM-63 and the launch of the final clinical phase for this Nutrition Healthcare product, entirely financed by Nestlé Health Science, we have demonstrated the soundness of our development model. We are now moving confidently towards marketing and claim submission for TOTUM-63 and, thanks to a solid financial position, we are also working to apply this same model to the rest of our Nutrition Healthcare portfolio. At the head of the
Bittrex Global to Operate Cryptocurrency Exchange From Bermuda30.9.2020 17:16:00 CEST | Press release
Bittrex Global (Bermuda) Ltd. received a full Class F Digital Assets Business Act license to operate its acclaimed cryptocurrency exchange under the supervision of the Bermuda Monetary Authority (BMA). The Bermuda-based entity will provide Bittrex Global with an additional important gateway for global accounts. From its Bermuda hub, Bittrex Global (Bermuda) will offer additional digital asset services over time subject to further approval by the BMA, such as futures. “The entire crypto industry is about looking forward,” said Bittrex Global’s CEO Tom Albright. “Working with the Bermuda Government and the BMA to be part of another regulatory community that keeps innovating is extremely exciting and is an important step in increasing crypto’s penetration at all levels of the financial industry.” Bermuda Premier David Burt added “attracting Bittrex Global to Bermuda is a significant achievement. As one of the leading global exchanges, Bittrex Global’s choice of Bermuda for expanding their
GA Telesis Plans to Deliver Renewed Confidence in Air Travel Through its New Global Distribution Agreement with Honeywell for a State-of-the-Art UV Cabin Cleaning System30.9.2020 16:50:00 CEST | Press release
In an effort to help restore confidence to the flying public, GA Telesis, LLC, has teamed with Honeywell and entered into a distribution agreement to act as a global distributor for their UV Aircraft Cabin Cleaning system. This partnership is another step in the development of GA Telesis’Tarmac Solutions Group's ability to offer a fully comprehensive Specialized Tooling and Ground Support Equipment solution for airlines around the world. This cabin system utilizes Ultraviolet (UV) light to quickly traverse an aircraft cabin, galleys & lavatories in less than ten minutes. In addition to measures already being taken by airlines in flight like the use of cabin air exchange and HEPA filters, this new system, when properly applied, reduces certain viruses and bacteria on airplane cabin surfaces and can assist in creating a cleaner environment for passengers and crew after the airplane lands and before each flight. The UV cabin cleaning system is intended to help instill confidence to busine
Velodyne Lidar Announces Inaugural Trading on Nasdaq Global Select Market30.9.2020 15:31:00 CEST | Press release
Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today announced shares of its common stock and warrants have begun trading on The Nasdaq Global Select Market under the ticker symbols “VLDR” (common stock) and “VLDRW” (warrants). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200930005166/en/ Velodyne Lidar is the first public pure-play lidar company and is known worldwide for its broad portfolio of breakthrough lidar technologies, including revolutionary sensor and software solutions. (Photo: Velodyne Lidar, Inc.) Velodyne is the first public pure-play lidar company and is known worldwide for its broad portfolio of breakthrough lidar technologies, including revolutionary sensor and software solutions. These innovative technologies deliver performance, quality and flexibility to meet the needs of a wide range of industries such as autonomous vehicles and growing new markets. Currently, Velodyne serves the automotive industry with
97% of PeopleSoft Licensees Believe Current Releases Meet Their Needs30.9.2020 15:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of business software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today revealed significant findings from its recent survey of Oracle PeopleSoft licensees, which was conducted to better understand licensees’ software product and release roadmap strategies, current challenges and application support and operating plans. The survey highlights that an overwhelming 97% of respondents believe their current PeopleSoft releases meet all or most of their business needs. Further, many licensees are taking steps to maximize the value and extend the lifespan of their robust and mature current releases, including moving their PeopleSoft software to a cloud hosting platform, utilizing Application Management Services and switching their annual support to third-party support providers like Rimini Street. This press release features multimedia. View the full release
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom