Business Wire

FDA Grants Breakthrough Device Designation to Impella ECP, the World’s Smallest Heart Pump

Share

The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210818005373/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Impella ECP, the world's smallest heart pump, is placed percutaneously into the heart's left ventricle, expands, and supports the heart’s pumping function, providing flow greater than 3.5 L/min. (Photo: Business Wire)

Impella ECP is the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. It measures 9 French (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min.

The FDA granted breakthrough device designation in part based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA regulated early feasibility study. In granting the designation, the FDA determined Impella ECP meets the FDA’s stringent requirements for a breakthrough device.

“This is yet another validation from the FDA of the clinical benefits of Impella technology and an affirmation of the innovative nature of Impella ECP which, due to its smaller vascular access size, has the potential to provide even safer procedures and be available to more patients who need hemodynamic support for coronary revascularization,” said Chuck Simonton, MD, Abiomed’s chief medical officer.

In the United States, an estimated 440,000 patients are indicated and yet undertreated for high-risk PCI. Impella ECP’s size may enable more physicians to provide critical hemodynamic support to coronary artery disease patients who need it.

The first Impella ECP patient in the world is Robert Matthews, an 80-year-old retired auto worker from Detroit, a father of four, and grandfather of eleven. For more than 20 years, Robert lived with heart disease and endured multiple procedures. In 2020, he was referred to Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit. Dr. Kaki discovered multiple blockages and poor heart function and identified Robert as an appropriate candidate for a Protected PCI with Impella. Robert became the first patient in the world treated with Impella ECP when Dr. Kaki inserted the heart pump prior to opening blockages and placing stents.

Two days later, Robert returned home, and his family and friends immediately noticed his renewed energy. Today, Robert is grateful for the cutting-edge technology that restored his quality of life.

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

ABOUT IMPELLA HEART PUMPS

The Impella 2.5® and Impella CP® devices are U.S. FDA 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 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.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For further information:

Tom Langford
Director of Communications
978-882-8408
tlangford@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

Spirit of Wipro Run Brings Together Participants From Over 35 Countries26.9.2021 15:57:00 EEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 16th annual ‘Spirit of Wipro’ (SOW) Run, drawing thousands of participants from over 35 countries to run together in spirit. For the past sixteen years, Wiproites around the world have come together to celebrate Wipro’s core values. The annual SOW run aims to inspire employees to be responsible citizens of the world. This year’s theme was “Together. To greatness,” inspired by the resilience demonstrated by Wiproites in a year of unprecedented disruption. Along with outperforming across all business parameters, Wipro teams have remained committed to supporting their colleagues and creating a lasting social impact across communities. Like last year, this year’s race was also virtual, and runners strictly adhered to the local COVID-19 guidelines and safety protocols while participating in the event. Even under these conditions,

Pencil Lab Inks Debut in ADIHEX 202125.9.2021 13:04:00 EEST | Press release

The 18th edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) on September 27 - October 3 marks an opportune platform for Pencil Lab Design Studio’s first major participation in the massive event, the largest of its kind in the Middle East and Africa. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210925005016/en/ Pencil Lab Inks Debut in ADIHEX 2021 (Photo: AETOSWire) Featuring more than 800 brands and companies, the event is held under the theme of ‘Sustainability and Heritage… A Reborn Aspiration’, highlighting heritage, culture and authentic sports and their strong relation with Arab history. As part of its inaugural participation in a major exhibition as a company, Pencil Lab, a UAE initiative, will showcase their artworks with three large oil paintings by Pencil Lab’s citizen artist, to highlight the strong connection of arts, like painting and photography, to Arab history and civilization.

DXC Technology Completes Refinancing Actions24.9.2021 23:30:00 EEST | Press release

DXC Technology Company (NYSE: DXC) (“DXC”) today announced the completion of its refinancing. DXC previously completed the offering of €1.35 billion Senior Notes priced on September 2, 2021 and $1.35 billion Senior Notes priced on September 7, 2021. DXC completed redemption of $2.5 billion principal of (i) EUR term loan in the amount of €400 million due FY23 and FY24, (ii) $500 million 4.25% Senior notes due FY25, (iii) £250 million 2.75% Senior notes due FY25, (iv) $467 million 4.125% Senior notes due FY26, (v) $500 million 4.75% Senior notes due FY28, and (vi) $234 million Senior notes due FY30. The applicable make whole premium for these redemptions was $300 million and accrued and unpaid interest was $40 million. Ken Sharp, Chief Financial Officer, DXC commented: “Our opportunistic debt refinancing of $2.5 billion of our high coupon debt further solidifies our financial foundation by extending our debt maturities, lowering our maturity towers and reducing our ongoing interest expen

Schlumberger Announces Third-Quarter 2021 Results Conference Call24.9.2021 17:00:00 EEST | Press release

Schlumberger Limited (NYSE:SLB) will hold a conference call on October 22, 2021 to discuss the results for the third quarter ending September 30, 2021. The conference call is scheduled to begin at 9:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (844) 721-7241 within North America or +1 (409) 207-6955 outside of North America approximately 10 minutes prior to the start of the call and the access code is 8858313. A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until November 22, 2021, and can be accessed by dialing +1 (866) 207-1041 within North America or +1 (402

Tradeweb Successfully Completes its First Southbound Bond Connect Transactions24.9.2021 15:07:00 EEST | Press release

Tradeweb Markets Inc. (Nasdaq: TW), a leading global operator of electronic marketplaces for rates, credit, equities and money markets, today announced it has completed its first Southbound Bond Connect transactions via the trading link between Tradeweb and China Foreign Exchange Trade System (CFETS). “Southbound Bond Connect is the latest evolutionary step for China’s financial market, providing domestic investors with more flexibility and choice when trading offshore bonds,” said Lee Olesky, CEO of Tradeweb Markets. “Together with CFETS, our goal is to better meet onshore investors’ demand for streamlined access to global investment. We will continue to focus on further enhancing the trading link by deploying new innovative trading functionality, just as we did with the Northbound leg of Bond Connect.” Southbound Bond Connect facilitates fixed income portfolio diversification for institutional investors in China. Tradeweb collaborates closely with CFETS to create a uniform trading ex

H.I.G. Capital Acquires Aspire Pharma24.9.2021 15:05:00 EEST | Press release

H.I.G. Capital, LLC (“H.I.G.”), a leading global alternative investment firm with $45 billion of equity capital under management, is pleased to announce that one of its affiliates has acquired Aspire Pharma Limited (“Aspire” or the “Company”), a leading UK provider of niche generic and branded specialty pharmaceuticals, alongside its founder Graham Fraser-Pye. The financial terms of the transaction have not been disclosed. Aspire licenses and develops niche generic and specialty pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets that are often underserved. The business holds leadership positions in urology, ophthalmology, CNS and dermatology, with a highly diversified portfolio of more than 250 products across multiple categories, including branded specialty products and unbranded niche generics. H.I.G., together with the management team, aims to continue Aspire’s strong track record of organic growth and

Swappable Announces Partnership with Esports T1's Dota 2 Team24.9.2021 14:34:00 EEST | Press release

Swappable, an NFT (Non-Fungible Token) interface for high-profile and exclusive digital collectibles, has announced its partnership with T1's Dota 2 team, the popular esports team for the upcoming International 10 - Dota 2 World Championship in Bucharest, Romania. T1 is not just an esports team but a pop culture phenomenon with millions of fans worldwide. The team embodies a blend of lifestyle, creativity and attitude, fresh from the source of Seoul & LA. As part of the collaboration, T1 will auction their first-ever NFTs (digital collectibles) on Swappable for T1’s Genesis Collection. With the first auction starting Friday September 24th, T1 will release a series of NFTs each possessing utility features such as special access to T1's Dota 2 team players and more. Visit Swappable for more information. “We are excited to partner with a leading organization in the esports industry. It is also a chance for T1 fans to pick the very first digital collectibles ever created by this legendary

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