Abiomed (Nasdaq:ABMD) today announced that the FDA has approved a version of Impella ECP for future pivotal trials.
Abiomed, based in Danvers, Massachusetts, enrolled the first two patients in the trial following approval. Dr. Amir Kaki, director of mechanical circulatory support at Ascension St. John’s Hospital in Detroit, led the procedure.
A single-arm, prospective, multi-center testing center centered on the Impella ECP support. Patients receive heart pumps during elective or emergency high-risk percutaneous coronary intervention (PCI). To assess the incidence of major cardiovascular and cerebrovascular events (MACCE) in adult patients.
The world’s smallest heart pump, the Impella ECP is compatible with small-bore access and closure techniques. According to the news release, it comes in at 9 Fr in diameter during insertion and removal from the body. Once in the body, it expands and supports the pumping function of the heart. The Impella ECP provides peak flows of up to 5 liters per minute.
“The Ascension St. John research and clinical team is pleased to enroll the first patient in the Impella ECP FDA pivotal trial.” Said Dr. Persimmon. “Impella ECP provides critical hemodynamic support for physicians during high-risk PCI procedures by providing comparable or superior flow compared to other options through a smaller vascular sheath for access. Facilitating Opportunities: This technology has the potential to improve patient safety and cath lab throughput due to the small arteriotomy required for pump placement.”
Learn more about the Abiomed Impella ECP
Both patients enrolled in the study received Impella ECP support during the difficult procedure of a left coronary artery bifurcation stent with severe calcified lesions. After removal of Impella ECP, the first patient was closed with her 8 Fr closure device.
Impeller ECP Received FDA approval for early feasibility study in June 2020The trial includes 54 previously treated patients.
pump It then received FDA Breakthrough Device designation in August 2021.This remains an option available for research purposes only.
Abiomed Chairman, President and CEO Mike Minogue said: “At Abiomed, we continue to develop smaller, smarter and more connected technologies that improve outcomes for heart patients. I applaud for.”
For those who missed
Not related to this particular news, but related to the acquisition by Abiomed. Johnson & Johnson (NYSE:JNJ) is on track.
Last month, Johnson & Johnson Announces intent to acquire Abiomed for approximately $16.6 billionUnder the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Abiomed through a tender offer.
Johnson & Johnson said the acquisition expands the position of its Johnson & Johnson Medtech business as a cardiovascular innovator. Abiomed’s products offer Johnson & Johnson “significant expansion opportunities” in indications, geographies and products.
