Showing posts with label Emergency. Show all posts
Showing posts with label Emergency. Show all posts

February 6, 2014

New Emergency Medical Intervention Can Save Life’s in Battlefield and at Most Shootings




 

Dealing with gunshots wounds on the battlefield is a brutal process. The only way to stop the bleeding is to stuff the wound with gauze, sometimes as deep as five inches into the body - and even then the treatment can fail, meaning the gauze has to be removed and new material put in.
Using this almost medieval process it's no surprise that haemorrhaging is still the leading cause of death for soldiers in the field.
Now a company named RevMedx has designed a device that they claim can stop a wound bleeding in just 15 seconds. This is the XStat, a modified syringe that injects tablet-sized sponges directly into the wound and that was inspired by the design of emergency tire repair kits.
“That’s what we pictured as the perfect solution: something you could spray in, it would expand, and bleeding stops,” John Steinbaugh, a US Army Special Operations medic who joined RevMedx told Popular Science. “But we found that blood pressure is so high, blood would wash the foam right out.”
So instead of foam Steinbaugh and his team experimented with sponges cut into 1-centimetre pills. Like the foam these sponges expand to fill the wound cavity, but they also adhere to moist surfaces, creating enough pressure to ensure that the bleeding stops.
How the XStar works to seal a wound. Image credit: RevMedX
RevMedx experimented with animal injuries and after early successes (and $5 million in funding from the US Army) they finessed the material, using sponges made from wood pulp and coated with a blood-clotting, antimicrobial substance called chitosan. Each sponge is also marked with a special X that show up on X-rays, ensuring that none of the pills are left within the body.
Using the XStat is also incredibly simple. Medics or other soldiers would simply insert the end of the syringe into the wound and push down the plunger to inject the sponges. The device is currently awaiting FDA approval in the US, but RevMedx are already pushing ahead, developing three different sizes of the XStat to treat a variety of wounds. Each syringe is made from lightweight polycarbonate and is expected to cost around $100.
"I spent the whole war on terror in the Middle East, so I know what a medic needs when someone has been shot," Steinbaugh told Popular Science. "I’ve treated lots of guys who would have benefitted from this product. That’s what drives me.”

March 20, 2013

Ur Lawmaker} Go to the ER if Afterwords the Pain is Gone and it Shows NO Emergency, You Pay


The US Food and Drug Administration (FDA) has completed its review of Pharmaxis' New Drug Application (NDA) for its dry powder formulation of mannitol (Bronchitol, Pharmaxis) and has recommended that the company conduct an additional study to obtain marketing approval in the US, Pharmaxis announced today.
"The submitted data do not provide a favorable benefit-risk balance to support the use of inhaled mannitol in patients with cystic fibrosis 6 years of age and older," the FDA said in a complete response letter to the company.
"The determination of efficacy based on the 2 clinical trials conducted to date are not adequate because of the treatment-related frequent early dropouts in trial 301 for which the primary statistical analyses did not account and the lack of statistical significance in trial 302 for the primary endpoint," the agency stated.
In relation to safety, Pharmaxis said the FDA expressed concerns over the occurrence of hemoptysis, particularly in patients younger than 18 years. 
Pharmaxis CEO Gary Phillips said the company is "clearly disappointed" in the FDA's decision, but noted that the regulator has provided guidance on the necessary measures to gain approval and that Pharmaxis will meet with the FDA soon to determine appropriate parameters of an additional clinical trial.
The complete response letter follows a unanimous decision January 30 by the FDA's Pulmonary-Allergy Drugs Advisory Committee against approval of Bronchitol for the management of cystic fibrosis in patients aged 6 years and older to improve pulmonary function.
The FDA previously granted Bronchitol orphan drug designation for the treatment of patients with cystic fibrosis.
Bronchitol, which helps facilitate mucus clearance in the lungs of patients with cystic fibrosis, is approved for marketing for patients aged 6 years and older in Australia and for patients aged 18 years and older throughout the European Union.

The US Food and Drug Administration (FDA) has completed its review of Pharmaxis' New Drug Application (NDA) for its dry powder formulation of mannitol (Bronchitol, Pharmaxis) and has recommended that the company conduct an additional study to obtain marketing approval in the US, Pharmaxis announced today.
"The submitted data do not provide a favorable benefit-risk balance to support the use of inhaled mannitol in patients with cystic fibrosis 6 years of age and older," the FDA said in a complete response letter to the company.
"The determination of efficacy based on the 2 clinical trials conducted to date are not adequate because of the treatment-related frequent early dropouts in trial 301 for which the primary statistical analyses did not account and the lack of statistical significance in trial 302 for the primary endpoint," the agency stated.
In relation to safety, Pharmaxis said the FDA expressed concerns over the occurrence of hemoptysis, particularly in patients younger than 18 years.
 Pharmaxis CEO Gary Phillips said the company is "clearly disappointed" in the FDA's decision, but noted that the regulator has provided guidance on the necessary measures to gain approval and that Pharmaxis will meet with the FDA soon to determine appropriate parameters of an additional clinical trial.
The complete response letter follows a unanimous decision January 30 by the FDA's Pulmonary-Allergy Drugs Advisory Committee against approval of Bronchitol for the management of cystic fibrosis in patients aged 6 years and older to improve pulmonary function.
The FDA previously granted Bronchitol orphan drug designation for the treatment of patients with cystic fibrosis.
Bronchitol, which helps facilitate mucus clearance in the lungs of patients with cystic fibrosis, is approved for marketing for patients aged 6 years and older in Australia and for patients aged 18 years and older throughout the European Union.

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