Drug news

FDA 510(k) clearance for LifeSPARC system advanced circulatory support (ACS) pump

Read time: 1 mins

Last updated:23rd Jul 2019

Published:20th Jul 2019

Source: Pharmawand

LivaNova PLC announced it has received 510(k) clearance from the FDA for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC begins a new chapter for ACS innovation within the LivaNova portfolio.

LivaNova expects to commence the limited commercial release of LifeSPARC in the United States later this year, with full commercial release expected by the end of 2019. Availability in other countries is anticipated to begin in 2020.

Built around a common compact console and pump, LifeSPARC provides temporary support for emergent rescue patients in a variety of settings. Designed for ease of use, the system offers more power and versatility for multi-disciplinary programs to support more patients. The system is accompanied by four specialized and ready-to-deploy kits, each designed to support diverse cannulation strategies.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Related news and insights

Drug news

Safety of switching from a Vitamin K antagonist to a non–Vitamin K antagonist oral anticoagulant in frail older patients with atrial fibrillation.

FRAIL-AF trial investigators set out to study the question of whether frail, elderly patients with atrial fibrillation who were doing well with vitamin K antagonists (VKA) should be switched to direct-acting oral anticoagulants (DOAC).

1 mins

Drug news

FDA approves updated Lupkynis (voclosporin) label to include long term data from the Aurora Clinical Program.-- Aurinia Pharmaceuticals.

Aurinia Pharmaceuticals Inc. announced that the FDA has approved a label update for Lupkynis. The updated label no longer includes language indicating that the safety and efficacy of Lupkynis has not been established beyond one year.

3 min

Drug news

Phase III KEYNOTE-811 trial met dual primary endpoint of overall survival (OS) as first-line treatment in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.- Merck Inc.,

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III KEYNOTE-811 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival (OS) for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

1 min

See all news