Business Wire

First Patients Treated with the World’s Smallest Heart Pump, the 9Fr Impella ECP

Share

Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world. It measures 9 French (Fr) (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5 L/min.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005398/en/

Impella ECP is the world’s smallest heart pump. (Graphic: Business Wire)

Impella ECP is the world’s smallest heart pump. (Graphic: Business Wire)

The first Impella ECP patient was treated by Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, part of Ascension Michigan. The patient had severe narrowing of his coronary arteries. Dr. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP including atherectomy and two one-minute long balloon inflations.

The second patient was treated at The Christ Hospital in Cincinnati by Timothy Smith, MD, an interventional cardiologist and director of cardiovascular intensive care unit, cardiogenic shock and ECMO programs. The patient had severe narrowing of the coronary arteries, including complex left main bifurcation disease and low ejection fraction. Percutaneous coronary intervention was successfully performed with support from Impella ECP.

“Ascension St. John Hospital is pleased to be the heart center leading this patient milestone as part of the early feasibility study of the smallest heart pump in the world,” said Dr. Kaki. "This new technology allows for a less invasive approach which may ultimately lead to better healing and recovery.”

“This groundbreaking technology will help more physicians provide critical hemodynamic support to patients who need it,” said Dr. Smith. “In the patient we treated, Impella ECP enabled the procedure by providing hemodynamic stability while we treated complex disease in a patient with low ejection fraction.”

Impella ECP is being studied under a U.S. Food and Drug Administration (FDA) early feasibility study. It is designed to provide temporary circulatory support and left ventricular unloading in patients undergoing a high-risk PCI. Impella ECP is delivered though a slender profile 9Fr sheath. It is un-sheathed in the descending aorta and expands. Then, using a specially designed pigtail, it crosses the aortic valve without a wire, and pumps from inside the left ventricle. When the procedure is complete, the pump is re-sheathed back down to 9Fr and removed.

“Impella ECP is part of Abiomed’s commitment to continually innovate, patent new breakthroughs, and improve patient outcomes by developing smaller, smarter, and more connected technology,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.

The primary endpoint of the FDA early feasibility study is successful delivery, initiation and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. The study protocol will enroll and treat up to five U.S. patients who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval.

Impella ECP is an investigational device, limited by federal law to investigational use only.

ABOUT ABIOMED

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 LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD Study, STEMI DTU and Automated Impella Controller are pending trademarks of Abiomed, Inc.

FORWARD-LOOKING STATEMENTS

Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contact information

Sarah Karr
Communications Manager
978-882-8211
skarr@abiomed.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Ipsen Receives FDA Fast Track Designation for Investigational Irinotecan Liposome Injection (ONIVYDE®) as a Second-Line Monotherapy Treatment for Small Cell Lung Cancer (SCLC)1.12.2020 00:58:00 EETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for irinotecan liposome injection (ONIVYDE®) in study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, reflecting the unmet medical need. ONIVYDE® is currently approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. An ongoing Phase III randomized study (RESILIENT; NCT03088813) trial is being conducted to assess the efficacy and safety of investigational irinotecan liposome injection (ONIVYDE®) as a monotherapy for SCLC study patients who have progressed on or a

Amblin Partners Announces New Multi-Year Film Distribution Partnership With Universal Filmed Entertainment Group1.12.2020 00:00:00 EETPress release

Amblin Partners today announced a new multi-year film distribution partnership with Universal Filmed Entertainment Group, as well as a series of new agreements that chart a clear course for the next phase of growth for one of the world’s leading independent film and television studios. The new deals were announced this morning by Steven Spielberg, Amblin’s Founder and Chairman. Remarked Spielberg: “My decades-long relationship with Universal truly transcends any single business deal, and to once again renew our corporate vows reaffirms that Universal is Amblin’s home. In addition to Universal, we are blessed to continue forward with a global family of partners, including Alibaba, eOne and Reliance, each of which has supported us for many years and enabled our storytelling to touch the lives of millions of moviegoers around the world. I would also like to extend my deepest gratitude to my dear friends Jeff Skoll and David Linde for an incredible run as formal partners; and my congratula

Little Cinema Taps Verimatrix To Secure Hollywood’s Virtual Premiere Events30.11.2020 19:45:00 EETPress release

Regulatory News: Verimatrix, (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced that New York-based Little Cinema deployed Verimatrix Watermarking and Multi-DRM technologies for its virtual premieres and previews. A groundbreaking digital studio, Little Cinema has partnered with Netflix, ABC, CBS, HBO Max, and Warner Media to produce state-of-the-art virtual premiere events for an industry that used to rely solely on in-person debuts. To fulfill the enhanced protection requirements for this high-value early-release content, Little Cinema looked to Verimatrix and its Secure Cloud. These innovative and highly-interactive virtual streaming events have made waves in Hollywood, earning the studio recognition in BBC News, Vogue, Variety, Vanity Fair, The Hollywood Reporter, and more. “Verimatrix supplies us with the needed anti-piracy protections and overall peace of mind that Hollywood studios demand when switching to virtual events

Emory University to Host a Live Webcast With His Holiness the Dalai Lama30.11.2020 18:39:00 EETPress release

The Center for Contemplative Science and Compassion-Based Ethics at Emory University will host a live webinar with His Holiness the Dalai Lama on Tuesday, December 8, 2020. A discussion titled “The Necessity of Compassion for the Survival of Humanity” will feature the Dalai Lama in conversation with Melani A. Walton, co-founder of the Rob and Melani Walton Foundation, and Dr. Sanjay Gupta, chief medical correspondent for CNN. (For speaker photos click here.) The webcast begins at 10:30pm ET on Dec. 8, 2020 (Dec. 9 @ 9:00am India Standard Time) and will be simulcast in 14 languages. It is FREE of charge and open to anyone who’d like to participate. Advance registration is encouraged at https://compassionshift.emory.edu. “With so many urgent concerns impacting our world, the time is right to start a global conversation about the importance of compassion,” said Lobsang Tenzin Negi, executive director of Emory University’s Center for Contemplative Science and Compassion-Based Ethics. “For

Flexjet Advances European Expansion with Delivery of First Embraer Praetor 60030.11.2020 17:03:00 EETPress release

Flexjet Ltd., offering travelers access to the world’s most luxurious fleet of private jets, accepted delivery of the first Praetor 600 aircraft in its European-based fleet, marking a significant milestone in the expansion of the company’s global business. Flexjet is the only shared-ownership/fractional provider of the Praetor 600, part of a US$1.4 billion order for Embraer Executive Jets, a division of Embraer S.A. (NYSE: ERJ; BM&FBOVESPA: EMBR3), that was announced in October 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201130005564/en/ Flexjet Embraer Praetor 600 super midsized aircraft part of the European-based Flexjet fleet. (Photo: Business Wire) European Managing Director Marine Eugène leads the team headquartered at Flexjet House in the Mayfair neighbourhood in the west end of London. In addition, Flexjet has opened facilities including a European Tactical Control Centre in the United Kingdom to coordinate f

Kymeta™ Announces Commercial Availability of its Next-Generation Antenna, Terminal, and Services Making Mobile Global30.11.2020 17:00:00 EETPress release

Kymeta (www.kymetacorp.com)—the communications company making mobile global—announced that the Kymeta™ u8 and Kymeta Connect™ are available for government and commercial purchase after November 30, 2020, unlocking the potential of broadband satellite connectivity and cellular networks to satisfy the overwhelming demand for communications on the move. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201130005022/en/ Kymeta’s next-generation solutions are built for mobility and designed to meet the needs of global defense agencies, government, first responders, and commercial customers. Kymeta’s products and services have been field deployed for three years and the demand for the Kymeta u8 presales has already exceeded expectations. With the introduction of the Kymeta u8, the company has meaningfully increased antenna throughput and significantly reduced the total cost of ownership. Kymeta’s new products and services offer a bre

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