SeaStar Medical builds enrolment in pivotal trial for AKI device

SeaStar Medical is progressing its pivotal trial evaluating the usage of its Selective Cytopheretic System (SCD) in sufferers with acute kidney damage (AKI), with the corporate saying that 12 sufferers have now been enrolled.

The NEUTRALISE-AKI pivotal medical trial (NCT05758077) is predicted to enrol as much as 200 sufferers with AKI who require steady kidney substitute remedy (CKRT).

SeaStar Medical’s chief medical officer Kevin Chung stated that the corporate has enrolled 5 sufferers over the previous six weeks, in addition to activating further medical websites, based on a 28 December press launch.

There are 30 research websites within the US anticipated for the trial, as per ClinicalTrials.gov. 5 of those are at present within the recruiting stage. The trial enrolled its first patient in June 2023.

SCD is a sort of cell-directed extracorporeal remedy delivered by way of CKRT. It really works by selectively focusing on and neutralising neutrophils and monocytes – effector cells that play a key position in hyperinflammation. The neutralised cells are then returned again into the physique via the blood.  Usually, the overactivity of the immune system can result in organ injury and may even result in multi-organ failure.

SeaStar’s SCD machine was granted breakthrough device designation by the US Meals and Drug Administration (FDA) in October 2023.

Entry essentially the most complete Firm Profiles
available on the market, powered by GlobalData. Save hours of analysis. Achieve aggressive edge.

Firm Profile – free
pattern

Your obtain e-mail will arrive shortly

We’re assured in regards to the
distinctive
high quality of our Firm Profiles. Nonetheless, we would like you to take advantage of
helpful
determination for your small business, so we provide a free pattern which you could obtain by
submitting the beneath type

By GlobalData

The corporate expects to obtain FDA approval beneath a Humanitarian System Exemption (HDE) to be used in youngsters weighing 10 kilograms or extra with AKI and sepsis. Kids with a septic situation requiring steady CKRT anytime throughout the subsequent 30 to 45 days may even be indicated. In October 2023, the corporate obtained correspondence from the FDA signalling the machine to be approvable beneath HDE.

The machine’s rollout is predicted in Q1 2024, based on SeaStar.

The NEUTRALISE-AKI research’s main endpoint is a composite of 90-day mortality or dialysis dependency of sufferers handled with SCD. Sufferers receiving remedy with the SCD along with CKRT will probably be in comparison with sufferers within the management group solely receiving CKRT customary of care. A subgroup evaluation may even discover the potential effectiveness of SCD remedy in AKI sufferers with sepsis and acute respiratory misery syndrome.


Trending Merchandise

0
Add to compare
Medline Transport Wheelchair with Lightweight Steel Frame, Folding Chair is Portable, Large 12 inch Back Wheels, 19 inch Wide Seat, Teal
0
Add to compare
$150.09
0
Add to compare
Majestic Electric Wheelchairs for Adults,Foldable Lightweight Electric Wheelchair,Light Weight Folding Power Chair for Seniors,Portable Motorized Wheelchair,Durable Ultra Light Wheel Chair
0
Add to compare
$1,699.00
8%
0
Add to compare
Drive Medical EXP19LTRD Lightweight Expedition Folding Transport Wheelchair with Hand Brakes, Red
0
Add to compare
$189.99
0
Add to compare
McKesson Wheelchair, Swing Away Foot Leg Rest, Desk Length Arms, 20 in Seat, 300 lbs Weight Capacity, 1 Count
0
Add to compare
$188.84
0
Add to compare
Medline Wheelchair, Desk-Length Arms and Swing-Away Leg Rests, 18″ x 16″ Seat (W x D)
0
Add to compare
$169.99
0
Add to compare
Medline Steel Wheelchair with Elevating Leg Rests, Flip-Back Desk-Length Arms, 16-Inch Wide Seat
0
Add to compare
$179.99
0
Add to compare
Medline Steel Transport Wheelchair, Folding Transport Chair with 8-Inch Wheels, Full Length Armrests and Swing Away Footrests, 19-Inch Wide Seat
0
Add to compare
$113.99
0
Add to compare
ProBasics Standard Wheelchair – Flip Back Desk Arms – 250 Pound Weight Capacity – Black – Swing-Away Footrest – 18″ x 16″ Seat
0
Add to compare
$187.18
0
Add to compare
UU-ZHANG (only 15lb) Super Lightweight Transport Wheelchair. Easy to Travel, Locking Hand Brakes, User-Friendly, Folding, Portable. for Adults or Child (up to 220lbs)) …
0
Add to compare
$199.00
.

We will be happy to hear your thoughts

Leave a reply

Omnifero
Logo
Register New Account
Compare items
  • Total (0)
Compare
0
Shopping cart