Impella ECP: World’s Smallest Percutaneous Heart Pump Meets Primary Endpoint with Superior Clinical Outcomes in Pivotal Trial

Oct 28, 2024 22:15 CST Updated 22:15

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Johnson & Johnson (Abiomed) Unveils Its Smallest Cardiac Intervention Pump for the First Time at TCT2024 ConferenceImpella ECPClinical Study (IDE) Data:Reached the primary endpoint。

This study was conducted inUnited States 1256 patients were recruited from 8 centers. The following is the patient information.

Specific Research Data

The study demonstrated the safety and efficacy of Impella ECP in high-risk PCI procedures.
The MACCE (Major Adverse Cardiovascular and Cerebrovascular Events) rate at 30 days was 6.3%, significantly lower than the predefined performance goal.

70% of patients chose 8Fr Angio Seal as the first closure method, with a success rate of 92%.

PI Evaluation

"The study achieved the pre-set 30-day primary endpoint with a low complication rate. The 9Fr arterial access allowed for a high closure success rate of the 8Fr Angio Seal. The Impella ECP technology, featuring a small puncture hole and easy closure, offers benefits to both patients and physicians."

---Amir Kaki St. John Hospital and Medical Center

Impella ECPClinical studies have once again proven that Johnson & Johnson is technologically leading in this field. Despite many companies in the market claiming their intervention cardiac pumps possess numerous technical advantages (with some even surpassingImpella ECP), but these companies have not provided such large-scale clinical evidence in clinical practice (no clinical data means no persuasiveness).

Johnson & Johnson to AccelerateImpella ECPThe product will also initiate a larger-scale clinical trial (involving 500 patients), as sufficient clinical evidence is required for FDA approval.

At the same timeImpella ECPExcellent clinical data will also bring information to transcatheter heart pump companies in and outside China. The leading player's outstanding performance proves that this track is correct, which will allow them to gain more capital favor.

Impella ECP

Impella ECPYesThe world's smallest hemodynamic support heart pump, itsWith a diameter of only 9 F (3 mm). Despite its small size, its flow rate is not small, reaching over 3.5 L/min (peak flow rate can reach 5). L/min). Once the sheath is removed, it can expand to approximately 18 Fr.The postoperative removal process is also very simple, onlyRetract the cardiac pump back into the 9Fr protective sheath via the same path.Withdrawal is sufficient.

It uses a specially designed pigtail tube and is made of low-durometer polyurethane, thereforePigtail CatheterVery soft, it can guide the heart pump through the aortic valve without injury, like a guidewire, into the left ventricle.

Abiomed

AbiomedIt is a subsidiary of Johnson & Johnson, providing medical devices for circulatory support and oxygenation to patients worldwide.AbiomedThe product is designed to rest the heart by improving blood flow and/or providing sufficient oxygen to patients with respiratory failure.