Baxter Announces U.S. FDA Clearance of ST Set Used to Help Treat Acute Kidney Injury Patients in the Hospital
- ST Set previously obtained FDA Emergency Use Authorization (EUA) to help meet increased demand for continuous renal replacement therapy (CRRT) products during the COVID-19 pandemic
- Offers additional option to provide CRRT for patients in an acute care environment
“We are pleased to offer the ST Set to healthcare providers and hospitals in the
AKI is a sudden decrease in kidney function over a period of hours to days, often as a result of illness, trauma or infection. The sudden loss of kidney function leads to the accumulation of toxins and fluid in the blood that, if left untreated, may lead to death. AKI is an increasingly common complication of acute illnesses in intensive care units and hospitals1 2 3 and is one of many complications affecting COVID-19 patients. CRRT mimics many of the functions of the natural kidneyand is the cornerstone of treatment in patients with severe AKI.4 During CRRT, the patient’s blood passes through a special filter, such as the ST Set, where fluid and uremic toxins are removed before the cleaned blood is returned to the body.
TheST Set includes three sizes (ST60, ST100 and ST150) that allow the healthcare provider to choose the most appropriate option for the patient. It features Baxter’s proprietary AN69 membrane, which can adsorb toxins with basic residues on the surface by means of ionic interactions. The ST Set works with all CRRT modalities and most commonly used anti-coagulants.
Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Rx Only.For safe and proper use of these devices, including contraindications, refer to the full Instructions for Use.
Important Safety Information
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane. The Prismaflex ST set is for use only in conjunction with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). All treatments administered via the Prismaflex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismaflex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- Slow Continuous UltraFiltration (SCUF)
- Continuous Veno-Venous Hemofiltration (CVVH)
- Continuous Veno-Venous HemoDialysis (CVVHD)
- Continuous Veno-Venous HemoDiaFiltration (CVVHDF)
to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 set and ST150 is indicated for use in patients with a body weight equal or greater than 30kg (66lb) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
This release includes forward-looking statements concerning the ST Set, including potential benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other
Baxter, PrisMax, Prismaflex and AN69 are registered trademarks of
1 Siew ED, Davenport A: The growth of acute kidney injury: a rising tide or just closer attention to detail? Kidney Int 2015;87:46-61.
2 O'Connor ME, Kirwan CJ, Pearse RM, Prowle JR: Incidence and associations of acute kidney injury after major abdominal surgery. Intensive Care Med 2016;42:521-530.
3 Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL: World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol 2013;8:1482-1493.
4 Lins RL, Nephrol Dial Transplant. 2012;27:4252-4255