April 4, 2006

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April 4, 2006

April 4th – April 10th

April 6th: FDA Approves New Urologix CoolWave(TM) Control Unit

Urologix Inc. based in Minneapolis, develops, manufactures and markets minimally invasive medical products for the treatment of urological disorders. The company has developed and offers non-surgical, anesthesia-free, catheter-based treatments that use a proprietary cooled microwave technology for the treatment of benign prostatic hyperplasia (BPH), a condition that affects more than 23 million men worldwide.

Urologix Inc. has received permission, through the approval of three PMA supplements relating to new hardware and software, from the U.S. Food and Drug Administration to market its new CoolWave(TM) control unit. Urologix plans to launch CoolWave in the first quarter of fiscal 2007.

Fred B. Parks, Urologix Chairman and Chief Executive Officer commented, "CoolWave is the most important product development for Urologix in many years and reaffirms our company's technological leadership position. This product represents the culmination of over a decade of focus on the treatment of BPH, and incorporates the recommendations of our physician base. The introduction of CoolWave will intensify competition in the office-based BPH market."

April 9th: Medical Gas Mix-Ups FDA Proposes Regulations to Prevent Deaths

A rule to make medical gas container contents more easily/readily identifiable is being proposed by the FDA. The aim is to prevent deaths and injuries as a result of mistakes (and contamination medical gas).

Several types of gases are administered to patients, either in health care facilities or at home. Oxygen is frequently given to patients with respiratory conditions, such as emphysema.

Cases of deaths and injuries have been reported which resulted from mistakes. Over 8 deaths and 18 serious injuries have been reported over the last ten years in the USA.

The proposal is that portable medical gas containers:

have gas use outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
be identified by labels that wrap all the way around the tops of these containers;
have high-pressure medical gas cylinders painted according to a standard color-coding system that corresponds to the gases stored in them; and
Be dedicated to medical use and not converted from industrial use.

The proposed rule will supplement existing regulations, says the FDA.

April 10th: Atrium Medical Receives FDA Approval for Its Novel C-QUR(TM) Coated Mesh

Atrium Medical Corporation is pleased to announce it has obtained US FDA 510(K) approval for a new bio-absorbable coated surgical mesh product called C-QUR(TM) Mesh.

This new product is indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair - a common procedure performed more than 700,000 times in the US each year. This novel technology combines Atrium's industry leading ProLite Ultra(TM) polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable coating. Atrium's discovery of combining an inert thin wall polypropylene mesh with an Omega 3 biological coating in pre-clinical studies has demonstrated a minimization of peritoneal tissue attachment as well as a significant reduction in both foreign body reaction and inflammation, resulting in a well-healed, reinforced repair. The use of Atrium's all natural Omega 3 bio-absorbable coating with its advanced lightweight surgical mesh provides today's clinicians with a broad spectrum of options for both laparoscopic and open surgical repair.

Atrium Medical Corporation of Hudson, New Hampshire, celebrating 25 years of US based healthcare innovation manufactures over two million sterile medical devices each year which are distributed worldwide.

If you have any comments regarding this update, please email: info@mdiconsultants.com

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