Abiomed is a publicly traded medical devices company that develops and manufactures external and implantable circulatory support devices. The company has headquarters in Danvers, Massachusetts, and three additional offices in Germany, including Aachen, Berlin, and Tokyo. It employs more than 2,500 people worldwide. Here are some things to know about the company. Weigh its pros and cons before making a decision. You can learn more about the company, its products, and its history by reading on.
In a randomized trial of the Impella Abiomed heart valve replacement device, IQ data has shown a connection between higher hospital Impella volume and lower use of invasive hemodynamic monitoring. The database consists of more than 15,000 patients treated for acute MI cardiogenic shock. Overall, the study is expected to enroll more than 60,000 patients. The trial is currently in progress and could expand to additional sites as more data become available.
A transthoracic echocardiogram (TTE) showed global left and right ventricular dysfunction and an ejection fraction of 25. The patient was treated with continuous renal replacement therapy and inotropic therapy to provide hemodynamic support. He also had a diagnosis of systemic lupus erythematous and myocarditis. During the trial, the Impella CP circulatory support device was implanted via the femoral artery. However, the insertion process was complicated by constant bleeding at the access site. The patient required a transfusion. The patient eventually underwent heart transplantation.
Impella XR Sheath
The Abiomed Impella XR Sheath simplifies complex interventions and creates less trauma compared to large bore sheaths. The Impella XR sheath is already cleared by the FDA for use in the Impella 2.5 device. The Impella CP sheath is in development. Both products are expected to drive Impella product demand and revenue growth. These features are key to the success of the Impella XR Sheath.
The Impella XR Sheath is an expandable sheath that allows for small bore access and closure when used with the Impella ECP pump. It is designed to reduce trauma to the arterial access site and is expected to be approved for use in the U.S. during the fourth quarter of FY21. In addition to the Impella XR Sheath, Abiomed has completed the EFS for the Impella ECP. The Impella ECP is the smallest heart pump available and measures 9 Fr in diameter when implanted. When expanded, the device delivers peak flows of 3.5 L/min.
The Impella BTR, or bridge-to-recovery heart pump, is smaller than current LVADs and is implanted through the axillary artery. It pumps more than six liters of blood per minute. The new device is being studied in an early feasibility study by the FDA. It is intended to help people with class III or IV heart failure regain their native heart function. The device is also designed to allow patients to transition back to their hearts and to continue with adjunctive therapies, such as exercise. In addition, it allows for patients to be safely and permanently discharged from the hospital after a period of full hemodynamic support.
The study will enroll 10 patients at five hospitals. They will receive continuous monitoring by the device through its cloud-based software, called Impella Connect. The company plans to stream live cases to the headquarters so that engineers can consult with physicians on performance. Participants in the study will be monitored for 90 days. The study will be completed when the participants no longer need the pump to support their heart functions. When the study is complete, the device will be removed from the patients.
Abiomed has acquired Procardia, a medical device that offers a minimally invasive solution for patients with acute decompensated heart failure (ADHF). The device consists of an advanced catheter and controller that lowers cardiac filling pressures, supports decongestion, and improves renal and cardiac functions. The device has already been granted a breakthrough device designation from the FDA. Analysts at William Blair expect this acquisition to help the company overcome two years of commercial disruption.
While the company is focused on advancing Procardia’s technology through the regulatory process, it expects to provide a commercialization timeline later this year. The company also plans to acquire Breethe, an all-in-one life support system, for $30 million. This acquisition may prove to be a valuable addition for the company, which is undergoing regulatory approval for its Breethe device. But it is not without its drawbacks.