相关临床试验
36
11 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1981
进行中（未招募）
7
19.4%
已完成
9
25.0%
Enrolling By Invitation
1
2.8%
No Longer Available
1
2.8%
尚未招募
3
8.3%
招募中
5
13.9%
暂停
1
2.8%
终止
6
16.7%
Unknown
3
8.3%
暂无批准数据
- The FDA has classified a manufacturing defect in catheter introducer kits used with Impella heart pumps as a Class I recall, its most serious category, weeks after issuing an Early Alert. - The recall covers 14 French and 23 French introducer kits made by Oscor for Johnson & Johnson's Abiomed unit, sold individually and inside Impella pump sets across the U.S. and roughly three dozen other countries. - Abiomed identified a potential for the introducer sheath to leak at the sidearm, beneath the sheath cap, and along score lines, which could cause life-threatening hemorrhage in patients receiving blood thinners. - As of April 22, Abiomed reported eight instances of major bleeding and three complaints with corresponding patient deaths, though the company determined the deaths were not attributable to introducer leakage.
- The STEMI-Door to Unload trial found that using the Impella CP microaxial flow pump before cardiac stenting did not significantly reduce heart damage in severe heart attack patients without cardiogenic shock. - The study analyzed 527 patients across 55 emergency rooms in five countries, showing infarct size was similar between Impella and immediate PCI groups (30.8% vs 31.9% of left ventricular mass). - Bleeding and vascular complications occurred more frequently in the Impella group (30.8%), exceeding the safety performance goal of 26.5%. - Despite the negative primary endpoint, researchers noted that infarct size did not increase despite a 47-minute delay in treatment, suggesting potential beneficial effects on myocardial recovery.
- The FDA issued an early alert warning about differential pressure sensor malfunctions in Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pump devices. - The sensor malfunction causes inaccurate pump flow readings and placement signals on the automated controller, leading to incorrect clinical interventions. - As of January 15, Abiomed reported 22 serious injuries associated with the issue, though the devices' hemodynamic support capabilities remain unaffected. - Abiomed has issued updated use instructions recommending clinicians rely on manual P-level flow rates rather than controller display values.
- Johnson & Johnson is reportedly considering a complete acquisition of partner Protagonist Therapeutics, following years of successful collaboration on the first-in-class oral peptide icotrokinra for immune-mediated diseases. - Icotrokinra has demonstrated clinical superiority over competitor deucravacitinib in head-to-head trials and was recently submitted to the FDA for plaque psoriasis approval, with positive data also emerging in ulcerative colitis. - The potential acquisition exemplifies J&J's disciplined "partner, validate, acquire" M&A strategy, which has already delivered significant returns through recent deals including Abiomed, Shockwave Medical, and Intra-Cellular Therapies. - J&J's strategic portfolio reshaping, including the 2023 Kenvue spinoff and planned orthopedics separation, has generated approximately $14 billion in free cash flow in the first three quarters of 2025 to fuel acquisition activities.
- Johnson & Johnson announced plans to spin off its orthopedics business into a standalone company called DePuy Synthes within 18-24 months, generating $9.2 billion in fiscal year 2024 sales. - The separation aims to refocus J&J's medtech portfolio on higher-growth markets including cardiovascular and robotic surgery while creating what CEO Joaquin Duato claims will be the largest orthopedics company in the medical device space. - Former Smith & Nephew CEO Namal Nawana will lead the new orthopedics company, which competes in lower-growth markets compared to J&J's other medtech segments. - Following the spinout, J&J's medtech division will concentrate on cardiovascular, surgery, and vision businesses, continuing the company's portfolio transformation strategy initiated with the 2021 Kenvue consumer health separation.
- The FDA issued an alert on July 1, 2025, regarding a critical detection issue with Abiomed's Automated Impella Controllers that may fail to recognize connected blood pumps during console transfers or case startup. - The pump detection failure can result in inadequate hemodynamic support, posing life-threatening risks particularly for patients in cardiogenic shock who may not tolerate prolonged episodes of inadequate support. - As of June 13, 2025, Abiomed has reported three deaths associated with this controller issue, prompting urgent safety recommendations including maintaining backup consoles and specific protocols for device failures. - Healthcare facilities are advised to implement immediate action protocols when screens remain stuck for more than 20 seconds, including switching to backup consoles and restarting affected systems.
- The FDA has granted premarket approval to Johnson & Johnson MedTech's Impella 5.5 and CP heart pumps for pediatric patients with acute decompensated heart failure and cardiogenic shock. - The Impella CP is approved for children weighing at least 52kg, while Impella 5.5 is approved for those weighing at least 30kg, offering temporary ventricular support. - These left-sided heart pumps unload the heart's left ventricle, allowing it to rest while maintaining oxygenated blood flow throughout the body, facilitating heart recovery. - Johnson & Johnson MedTech collaborated with the ACTION network to gather real-world data supporting the use of Impella pumps in pediatric patients.
• The CLEAR SYNERGY (OASIS-9) trial found that spironolactone did not significantly improve composite outcomes in patients post-MI who underwent PCI compared to placebo. • An on-treatment analysis suggested potential benefits with spironolactone, but high drug discontinuation rates complicate interpretation of these findings. • Spironolactone was associated with a reduced risk of new or worsening heart failure in both intention-to-treat and on-treatment analyses. • The study highlights the challenge of demonstrating additional benefits with new therapies in a patient population already receiving optimal post-MI treatment.
- Johnson & Johnson's Impella ECP heart pump met its primary endpoint in a pivotal trial, positioning the company to seek FDA approval for the device. - The trial demonstrated a 6.3% rate of major adverse cardiac and cerebrovascular events after 30 days, below the predefined performance goal. - Impella ECP is designed for easier insertion and implantation compared to other heart pumps, potentially improving outcomes for high-risk PCI patients. - The device features a smaller introducer sheath, which facilitates easier access and closure techniques during percutaneous coronary intervention.
- Johnson & Johnson's Impella ECP heart pump met its primary endpoint in a pivotal trial, paving the way for FDA approval. - The trial demonstrated a 6.3% rate of major adverse cardiac and cerebrovascular events at 30 days, below the predefined performance goal. - Impella ECP is designed with a smaller introducer sheath, aiming for easier insertion and implantation compared to other heart pumps. - Data from 560 patients, including those in a continued access program, support the safety and efficacy of Impella ECP in high-risk PCI.
