Abiomed to Showcase Expanded FDA Indications and Next Generation Heart Recovery Products at TCT 2018

DANVERS, Mass., Sept. 19, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), the leader in heart recovery, announces its initiatives at the 30th Transcatheter Cardiovascular Therapeutics (TCT) conference will highlight the recently expanded FDA indications for high-risk PCI and cardiogenic shock. Initiatives will also highlight Protected PCI’s ability to allow for more complete revascularization, which improves outcomes¹ and quality of life^2,3. More than 30 presentations as well as live cases featuring Impella^® heart pumps are expected at TCT 2018, taking place September 21-25 in San Diego, California.

The FDA approved Impella CP® with SmartAssist™ includes hemodynamic sensors to intelligently position, manage and wean.

Advancing Heart Recovery

Visit booth #829 to learn more about Abiomed’s commitment to advancing the field of heart recovery through clinical research and innovation to improve outcomes and lower health care costs.

New for TCT 2018, Abiomed’s booth will feature a cath lab experience with demonstrations and simulations of advancements including:

• Abiomed’s augmented reality simulator which provides hands-on experience with the Impella RP and the newly FDA approved Impella CP^® with SmartAssist^TM, which includes hemodynamic sensors to intelligently position, manage and wean
• Simulations of Impella CP with SmartAssist’s real-time informational displays of new hemodynamic metrics
• Live demonstrations of Abiomed’s latest innovation, Impella Connect, which provides real-time information in the cloud to connect remote support resources

In the hemodynamic support and patient management pavilion, Abiomed is hosting practical, hands-on workshops on large bore access and closure, advanced hemodynamics, best practices in cardiogenic shock, and complex Protected PCI strategies.

Best Practices in Cardiogenic Shock and Updated Data from National CSI

A breakfast symposium on Saturday, September 22 at 6:30 a.m. will feature data on Abiomed’s FDA approval for cardiogenic shock associated with cardiomyopathy, including peripartum and postpartum cardiomyopathy. Faculty will also discuss the role of ventricular unloading and the latest results from the National Cardiogenic Shock Initiative (NCSI). Initial NCSI data showed 76% survival and 100% native heart recovery when the NCSI protocol and best practices were used. To register, click here.

Live Cases: Protected PCI with Impella Allows for More Complete Revascularization

Protected PCI with Impella allows for more complete revascularization, which improves outcomes and quality of life. Abiomed anticipates the broadcast of several elective high-risk PCI live cases using hemodynamic support with the Impella heart pump.

The schedule for Protected PCI and cardiogenic shock related TCT symposia is included below.

Saturday, September 22

Co-sponsored Symposium:New Treatment Strategies for Cardiogenic Shock: Impella Expanded Indications
6:30–8:00 a.m. | Room 23 B-C

• Cindy Grines, MD: Advances in the Treatment of Cardiovascular Disease in Women: PCI, MI, Shock, Myocarditis, SCAD, and Post-partum Cardiomyopathy
• William O’Neill, MD: The Impact of The Cardiogenic Shock Initiative (NCSI): One Year Later
• Navin Kapur, MD: Understanding the Importance of Ventricular Unloading in Management of AMI and Cardiogenic Shock

Presentation Theater Program: Contrast-Induced Acute Kidney Injury – Preventive Measures That Work 
Saturday, September 22 | 11:30 a.m.–12:30 p.m.
San Diego Convention Center, Presentation Theater 2, Hall B2, Ground Level

CHIP Angiogram Review: What’s New with Focused Case Presentations
Saturday, September 22 | 6:30–8:00 p.m.
Marriott Marquis San Diego Marina, Pacific Ballroom 18-19

Sunday, September 23

Co-sponsored Symposium: Management of Complex PCI Patients: Award-winning Case Presentations
6:30–8:00 a.m. | Room 23 B-C
Chair: David Wohns, MD
Faculty: Amir Kaki, MD; George Vetrovec, MD

Interactive Training Pavilion: Hemodynamic Support & Patient Management
Saturday, September 22 and Sunday, September 23

• Large Bore Access & Closure
  Faculty: Amir Kaki, MD; James McCabe, MD; Raj Tayal, MD
• Cardiogenic Shock (NCSI)
  Faculty: Navin Kapur, MD; William O’Neill, MD; Brian Porvin, MD
• TEACH Intro
  Faculty: Dan Burkoff, MD; Reshad Garan, MD; John Lasala, MD; Salvatore Mannino, MD; Perwaiz Meraj, MD; Lynn Morris, MD; Raj Patel, MD; Brian Porvin, MD
• Complex Protected PCI
  Faculty: Hiram Bezerra, MD; Dan Burkoff, MD; Mauricio Cohen, MD; Colin Hirst, MD; Paul Mahoney, MD; Duane Pinto, MD; Uma Rangasetty, MD; Adhir Shroff, MD

Monday, September 24

Annual Investor Breakfast

Abiomed will host an Annual Investor Breakfast on Monday, September 24, from 7:00 – 8:00 a.m. A prominent physician will present on Protected PCI and Cardiogenic Shock programs and protocols at his hospital. The company will also address new technology and innovation highlighted at TCT 2018, including Impella CP^® with SmartAssist^TM, and conduct Q&A with Abiomed management. Additionally, the company confirms that the STEMI DTU FDA feasibility study will be presented in detail November 11th at the American Heart Association (AHA), in Chicago, and will not be covered during this TCT event. Abiomed TCT Investor Breakfast slides will be posted at http://investors.abiomed.com/events-presentations. To request attendance, please email [email protected].

1. Dangas, G. et al. Am. Journ of Cardiol. 2014 Jan 15;113(2):222-8.
2. Abiomed data on file.
3. O'Neill, W. et al. Circulation. 2012 Oct 2;126(14):1717-27.

ABOUT IMPELLA HEART PUMPS

The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist, Impella 5.0® and Impella LD® are 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. 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.protectedpci.com.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering hearts. Saving lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.

ABOUT ABIOMED

Based in Danvers, Massachusetts, 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.

FORWARD-LOOKING STATEMENTS

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 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 Quarterly Report on Form 10-Q. 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.