Abiomed Commits Over $100 Million to Advance Impella Minimally Invasive Heart Pump Clinical Portfolio
VCBeat (WeChat Official Account: vcbeat) has learned that Abiomed, a U.S.-based company, recently publicly disclosed its clinical research commitments. In its statement, Abiomed revealed that it has invested over $100 million in clinical studies of the Impella heart pump over the past five years.
Abiomed was founded in 1981 and is headquartered in Danvers, Massachusetts, with the corporate mission of “Healing Hearts and Saving Lives.” As a leading global provider of heart circulation support devices, Abiomed develops, manufactures, and sells proprietary products that provide hemodynamic support to patients with heart failure, enabling their hearts to rest, heal, and recover.
Since the discovery of Impella technology in Germany five years ago, Abiomed has undergone a bold transformation, eliminating all LVAD (Left Ventricular Assist Device) R&D pipelines to focus exclusively on Impella technology. Today, Abiomed’s strategic core is entirely centered around the deployment of Impella technology.
The working principle of Impella technology is to reduce left ventricular end-diastolic pressure and intraventricular wall tension, thereby decreasing myocardial oxygen demand by improving the micromechanics of myocardial fibers.
Abiomed’s Impella device portfolio mainly includes the Impella 2.5, Impella 5.0, Impella CP, and Impella RP series, providing medical support to numerous patients worldwide.
Impella 2.5 is a percutaneous microaxial heart pump with an integrated motor and sensors for interventional cardiology; Impella 5.0 is a percutaneous microaxial heart pump with an integrated motor and sensors, primarily used in cardiac surgery settings; Impella CP provides circulatory support using an external console controller; Impella RP is the first FDA-approved percutaneous single-access cardiac pump, indicated for acute right heart failure following surgical implantation, myocardial infarction, heart transplantation, or open-heart surgery.
ImpellaRP® System
Abiomed’s research activities peaked over the past two years, with Impella being included in eight clinical guidelines¹ and sequentially receiving regulatory approvals including European CE marking, Japanese PMDA approval, and U.S. FDA (Food and Drug Administration) PMA (Premarket Approval).
In the United States, Germany, and Japan, more than 100,000 patients have received Impella therapy.
Abiomed entered the Japanese market in the second quarter of 2018, launching its Impella product portfolio.
In April 2018, Abiomed’s Impella 5.5 heart pump received CE marking in the European Union, and the first patient was treated at the University Heart Center Hamburg in Germany.
Tim Deits, a California resident, is a representative beneficiary of Impella therapy. After collapsing at his home in Huntington Beach, California, he went into cardiogenic shock. Thanks to the availability of the Impella RP heart pump at his local hospital, Tim was transported to the facility and treated with both the Impella CP and Impella RP devices, which allowed his heart to recover.
In its public commitments, Abiomed plans to continue actively supporting clinical research on Impella in 2019, including two randomized controlled trials.
“Commitment to clinical research is deeply rooted in Abiomed’s culture, as we are dedicated to providing healthcare providers and patients with the highest-quality devices and most cost-effective solutions,” said Seth Bilazarian, M.D., Chief Medical Officer of Abiomed. “Abiomed’s clinical research objective is to develop a comprehensive product portfolio throughout the entire continuum of cardiac recovery care, with a primary focus on the circulatory care space, and to continue leveraging this experience to develop other circulatory support products.”
(Compiled by: Tan Xin)