Archive for the ‘Canada Approval’ Category

Canadian Invention Will Soon be Saving International Lives

Friday, April 6th, 2012

ITClamp

An Afghanistan war veteran has created a new tool for paramedics and trauma surgeons. Similar in shape to a woman’s “butterfly clip,” this clamp is designed to speedily close traumatic wounds. After winning the top innovator award at the Life Science and Health Care Ventures Summit in New York, Dr. Filips and his firm, Innovative Trauma Care (ITC), hope to launch this device later this year. Dr. Filips plans to launch the ITClamp to the Canadian military, US and possibly New Zealand and Australia.

The ITClamp stands for Innovative Trauma Care clamp. It was formerly known as the Tactical Use Skin Closure device. The ITClamp is a group of small curved needles which are embedded within the ‘arms’ of the spring-loaded device. The edges of the wound are pulled together, and up, then clamped together. This stops serious bleeding almost instantly. Because the edges of the wound are lifted, the blood doesn’t have a channel to flow through. This immediately slows bleeding.

Dr. Filips came up with the idea after seeing first hand the difficulties paramedics have with serious and often multiple trauma wounds. Using the ITClamp allows for the paramedics and trauma surgeons to close all the wounds, then choose which is the most life-threatening and work on that (often an abdominal wound). The clamp comes in one size, but for large wounds, doctors can use multiple ITClamps. Dr. Filips expects hospitals to stock around 6 ITClamps in ambulances, and ER doctors could have around 20 on hand in the emergency room. Innovative Trauma Care is currently manufacturing test devices to send to national approval centres such as the United States’ Food and Drug Administraion. They expect approval within 3 months.

For more information see the Province’s original story here.

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Buy Brilinta – Canada approves AstraZeneca’s key new heart drug

Friday, June 3rd, 2011

New Heart Drug

Canadian regulators have approved AstraZeneca’s key new heart drug Brilinta, a boost for a product whose future in the all-important U.S. market is still uncertain.

The green light from Health Canada means the medicine is now approved in 33 countries, including in the European Union under the trade name Brilique, the drugmaker said in Wednesday.

Despite the growing tally of approvals, Brilinta’s prospects in the United States remain under a cloud because American patients taking it in a pivotal clinical trial appeared to do worse than those on rival Plavix.

Astra stressed the go-ahead from Health Canada was an independent regulatory decision and would have “no bearing” on the ongoing reviews of Brilinta in the United States or other markets.

The new drug is viewed as a potential multibillion-dollar seller that would compete with Sanofi and Bristol-Myers Squibb’s Plavix, but only if doctors are convinced it will work better. Plavix, the world’s second- biggest selling drug, brings in some $9 billion a year.

There has been speculation that the U.S. Food and Drug Administration (FDA) may ask for more evidence of the drug’s effectiveness in U.S. patients before approving it.

The FDA is due to make an approval decision on the drug, considered the company’s most important new product, by July 20.

More blood thinners list: Pradaxa Canada

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