MA-ABIOMED
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/
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210818005373/en/
Link:
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
Prilenia Enters into a Collaboration and License Agreement with Ferrer for the Commercialization and Co-Development of Pridopidine in Europe and Other Select Markets28.4.2025 07:02:00 CEST | Press release
-- Total deal size of approximately €500 million, including approximately €125 million in upfront and near-term milestones ---- Ferrer to commercialize pridopidine in Europe and other select markets; Prilenia retains full commercialization and development rights to pridopidine in North America, Japan and Asia Pacific ---- Co-development agreement in the territory supports further expansion of pridopidine in Huntington’s disease, amyotrophic lateral sclerosis and future indications ---- Pridopidine for Huntington’s disease is currently under review by the European Medicines Agency (EMA) with a CHMP opinion expected in the second half of 2025 -- Prilenia Therapeutics B.V., a biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS), today announced that it has entered into a collaboration and license agreement with Ferrer for the commercialization
Ferrer Enters Into a Collaboration and License Agreement With Prilenia for the Commercialization and Co-Development of Pridopidine28.4.2025 07:00:00 CEST | Press release
Ferrer, an international B Corp pharmaceutical company with an increasing focus on rare neurological diseases, and Prilenia Therapeutics B.V.,a clinical-stage biotech company, have announced the signing of a strategic co-development and license agreement in which Ferrer obtains the rights to develop, manufacture and commercialize Pridopidine in the European Region, the Middle East and North African Region, the Southern African Region, the Central and South American Region, and the Commonwealth of Independent States Region. Pridopidine, a potent and highly selective, orally administered sigma-1 receptor agonist, designed to regulate key neuroprotective mechanisms that are often impaired in neurodegenerative diseases, is a promising candidate for the treatment of Huntington’s Disease (HD), a rare inherited neurodegenerative disease, with a high unmet medical need1. It has been studied in more than 1,700 people and long-term safety data of up to 7 years duration are available from previou
Innorna Announces FDA Rare Pediatric Disease and Orphan Drug Designations Granted to IN013 for Treatment of Wilson Disease27.4.2025 11:36:00 CEST | Press release
Innorna, a clinical-stage biotechnology company revolutionizing mRNA therapeutics with its innovative lipid nanoparticle (LNP) delivery technology, today announced the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to its investigational mRNA therapy, IN013, for treating Wilson Disease (WD). This dual achievement accelerates the clinical development of IN013, advancing Innorna’s mission to deliver transformative therapies for WD patients. About FDA Designations The Rare Pediatric Disease Designation (RPDD) incentivizes therapies for serious or life-threatening diseases affecting fewer than 200,000 U.S. patients, primarily those aged 18 or younger. Sponsors may qualify for a Priority Review Voucher (PRV) upon approval to expedite FDA review of a subsequent drug application. The Orphan Drug Designation (ODD) supports therapies targeting rare diseases (affecting fewer than 200,000 U.S. patients) by provi
Everen Specialty Appoints Carla Greaves Chief Underwriting Officer25.4.2025 19:00:00 CEST | Press release
Everen Specialty, a Bermuda-based (re)insurer for energy markets worldwide, today announced the appointment of Carla Greaves as its new Chief Underwriting Officer (CUO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250425273777/en/ Carla Greaves Ms. Greaves will join the Executive Leadership Team of the Everen Group, based in the Bermuda office, later this year. She succeeds Jane Peterson, Interim CUO, who will continue in a consultancy capacity to facilitate the transition. With more than 30 years of underwriting and leadership experience in the (re)insurance industry, Ms. Greaves brings a wealth of expertise and a proven track record of success in the Casualty market where she is recognized for building high-performing teams, driving profitable growth, and successfully navigating complex market environments. Prior to joining Everen Specialty, Ms. Greaves held increasingly senior leadership positions, most recently servin
Incyte to Highlight Early-Stage Oncology Data at American Association for Cancer Research Annual Meeting 202525.4.2025 14:00:00 CEST | Press release
Incyte (Nasdaq:INCY) today announced that the Company will present new early-stage data from its oncology portfolio at the American Association of Cancer Research (AACR) Annual Meeting 2025 in Chicago, IL, from April 25–30. “At AACR we will be presenting data from early-stage programs across our oncology portfolio, including for patients with myeloproliferative neoplasms, ovarian cancer and other solid tumors,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “These data will guide our approach as we advance our pipeline and seek to transform the treatment landscape for patients with cancer and myeloproliferative neoplasms.” Abstracts accepted for presentation at AACR include: Mini Symposium INCB177054 INCB177054: A Novel, Potent, Orally Bioavailable DGKα/ζ Dual Inhibitor Enhances T-Cell Function and Demonstrates Potent Antitumor Activity (Session Title: Novel Antitumor Agents. April 28, 4:50 p.m. – 5:05 p.m. ET (3:50 p.m. – 4:05 p.m. CT). Abstract #
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