Abiomed (Nasdaq:ABMD) announced today that the FDA approved the version of Impella ECP for its upcoming pivotal trial.
Danvers, Massachusetts-based Abiomed enrolled the first two patients in its trial following approval. Dr. Amir Kaki, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, led the procedures.
The single-arm, prospective, multi-center trial centers around Impella ECP support. Patients either receive the heart pump during elective or urgent high-risk percutaneous coronary intervention (PCI). It evaluates the rate of major adverse cardiovascular and cerebrovascular events (MACCE) in adult patients.
Impella ECP, the world’s smallest heart pump, has compatibility with small bore access and closure techniques. According to a news release, it comes in at 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands and supports the heart’s pumping function. Impella ECP provides peak flows up to five liters per minute.
“The research and clinical teams at Ascension St. John are delighted about enrolling the first patients in the Impella ECP FDA pivotal trial,” said Dr. Kaki. ”Impella ECP advances the opportunity for physicians to provide critical hemodynamic support during high-risk PCI procedures by delivering similar or higher flow compared to other options through a smaller vascular sheath for access. This technology has the potential to improve patient safety and cath lab throughput because of the smaller arteriotomy required for pump placement.”
More on the Abiomed Impella ECP
Both patients enrolled in the trial received Impella ECP support during challenging left main coronary bifurcation stent procedures involving heavily calcified lesions. After the removal of Impella ECP, the first patient was closed with an 8 Fr closure device.
Impella ECP received FDA approval for an early feasibility study in June 2020. That trial includes 54 patients who received treatment to date.
The pump then received FDA breakthrough device designation in August 2021. It remains an option for investigational use only.
“Impella ECP demonstrates Abiomed’s leadership in technology and innovation as we have broken the small-bore barrier through the development of the world’s smallest heart pump,” said Mike Minogue, Abiomed’s chair, President and CEO. “At Abiomed, we remain committed to developing smaller, smarter and more connected technologies that will improve outcomes for patients with heart disease. I applaud the teams within the medical community and at Abiomed who helped us achieve this milestone.”
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Unrelated to this specific news but still relevant to Abiomed, its acquisition by Johnson & Johnson (NYSE:JNJ) remains on track.
Last month, Johnson & Johnson announced its intention to acquire Abiomed for approximately $16.6 billion. Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares.
Johnson & Johnson said the acquisition broadens its Johnson & Johnson MedTech business’ position as a cardiovascular innovator. Abiomed’s offerings provide Johnson & Johnson with “significant expansion opportunities” in indication, geography and product.