Johnson & Johnson MedTech, the unit of Johnson & Johnson (J&J), announced that the investigational device exemption (IDE) study of its Impella heart pump has met the primary endpoint.

The IDE study is the first clinical trial completed on patients supported with Impella ECP, a novel transvalvular axial flow pump with compressible pump architecture.

Impella ECP technology is developed by Abiomed, a company of Johnson & Johnson MedTech.

The IDE study established the safety and efficacy of Impella ECP in high-risk percutaneous coronary intervention (PCI), with a major adverse cardiac and cerebrovascular events (MACCE) rate of 6.3%.

St. John Hospital and Medical Centre mechanical circulatory support and complex coronary intervention director Amir Kaki led the IDE study as principal investigator.

Kaki said: “The study met its prespecified 30-day primary endpoint with low complication rates and the 9Fr arterial access enabled a high success rate closing with an 8Fr Angio-Seal. Impella ECP technology with small-bore access and closure offers benefits for patients and physicians.”

In a separate development, Johnson & Johnson MedTech’s subsidiary Shockwave Medical announced the completion of enrollment in the EMPOWER CAD clinical study.

EMPOWER CAD is the first all-female study of PCI in complex calcific disease.

The study is designed to determine the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population.

The EMPOWER CAD study enrolled 400 participants across 48 sites in five countries, where 71% of the enrolling sites were led by female principal investigators.

The European arm of the study was led by Nieves Gonzalo, a consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain.

EMPOWER CAD co-principal investigator Margaret McEntegart said: “The completion of enrollment in EMPOWER CAD is a major milestone in our desire to improve cardiovascular outcomes for women with challenging calcified lesions.

“Not only will this study yield valuable insights on the performance of coronary IVL in female patients, but as the first prospective all-comers study of coronary IVL, we also hope to gain additional insights about the utility of the technology in more complex patients.”