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July 4 – July 10

July 4^th: Data Show CHANTIX(TM) (varenicline) Provides Smokers New Hope to Quit Smoking

CHANTIX(TM) (varenicline) was shown to be effective with a favorable safety profile as an aid to smoking cessation treatment, according to three pivotal studies published in this week's Journal of the American Medical Association.

Chantix, the first new prescription smoking cessation medication approved in nearly a decade, received U.S. Food and Drug Administration approval on May 10. Chantix is expected to be available in U.S. pharmacies in August. Because smokers need considerable support to successfully quit, Chantix will be available to patients with a support program designed to help address behavioral components of smoking dependence. This personalized program will be offered at no additional cost and easy to use.

According to the World Health Organization, every eight seconds a person dies of a smoking-related disease.

Data show that approximately 44 percent of patients treated with Chantix (1mg twice a day) quit smoking by the end of the 12-week treatment period versus 30 percent who used buproprion SR (150mg twice a day) and 18 percent who used placebo. In an additional phase III clinical trial, patients who remained quit after 12 weeks of treatment with Chantix were randomized to receive an additional 12 weeks of treatment with Chantix or placebo. At the end of 24 weeks, 70.5 percent of patients on Chantix continued to abstain from smoking compared to 50 percent who switched to placebo.

In trials, Chantix was generally well tolerated with overall discontinuation rates similar to placebo. The most frequent side effects included nausea, headache, trouble sleeping and changes in dreaming.

In November 2005, Pfizer submitted a European marketing authorization application for varenicline for smoking cessation.
 

July 5^th: Cook Zilver Stent Receives FDA Approval for Vascular Use

In a milestone achievement for the company, Cook Incorporated has received U.S. Food and Drug Administration approval to market its Zilver Vascular Stent for use treating symptomatic vascular disease of the iliac arteries, the most common type of vascular disease.

"Peripheral vascular disease is a major health issue affecting millions of patients in the U.S. alone. Until recently, physicians have had limited options in treating vascular disease in the iliac arteries. But with this FDA approval, we now have an advanced stent design that can significantly aid patients with this condition," explained Barry Katzen, M.D., Medical Director of Baptist Cardiac and Vascular Institute, Miami, Fl. Dr. Katzen was primary investigator for the pivotal U.S. trial of the Zilver Vascular Stent.

The indication is the first FDA approval for vascular use of Cook's Zilver stent, a self-expanding nitinol device. Cook has regulatory approval to market the stent for vascular use in more than 25 countries, including Australia, Brazil, France, Germany, the United Kingdom, India, China, Taiwan, and others. Cook's submission to the FDA was supported by data from a 20-patient pilot study and a pivotal study evaluating 151 patients at 24 U.S. investigational sites.

Cook's Zilver Vascular Stent is indicated for use in the treatment of symptomatic vascular disease of the iliac arteries with a reference vessel diameter of 5 mm to 9 mm. The stent may be used to treat lesions up to 100 mm in length, according to the FDA indications.

The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK® is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures.
 

July 5^th: FDA Clears Lumen Biomedical Catheter for Removing Clots from Arteries

Lumen Biomedical, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its first product in the United States, the Xtract(TM) Aspiration Catheter. The new device is indicated for use in the removal of thrombi (clots) and soft emboli from vessels throughout the body. Clots can restrict or interrupt blood flow within an artery, creating complications in patients undergoing intravascular procedures. The Xtract(TM) Aspiration Catheter can be used with other devices during vascular intervention procedures, such as stents and embolic protection devices, to restore normal blood flow after blockages created by clots within the vessels.

The Xtract(TM) Aspiration Catheter, will provide cardiologists a novel tool to treat patients who have arteries laden with thrombus, such as patients experiencing acute myocardial infarction (acute heart attack). Its directional tip and favorable torque response allows physicians to treat difficult to reach segments of vessels. We are confident that with this device they will be able to successfully and completely remove thrombus from vessels that otherwise could not have been cleared."

The Lumen Biomedical, Inc (LBI) Xtract(TM) Aspiration Catheter is designed to remove fresh, soft emboli or thrombi from the arterial system. It is a single-use, 0.014" guidewire compatible, temporary intra-vascular extraction and aspiration catheter system. Lumen Biomedical, Inc. (LBI) is a medical device company established in 2003. The Xtract(TM) Aspiration Catheter will also be part of LBI's FiberNet® Embolic Protection System, which is currently under clinical evaluation in the United States.
 

July 6^th: Zimmer Holdings Receives U.S. Regulatory Approval to Begin Sale of Ceramic Hip Replacements

Zimmer Holdings, Inc a leader in the orthopaedics industry, announced today that it has received approval of its Premarket Approval Application (PMA) from the United States Food and Drug Administration (FDA) to market the Trilogy AB® Ceramic-on-Ceramic Acetabular System. In November 2005, the FDA issued an approvable letter indicating that the PMA was approvable subject to FDA inspection of the Company's facilities related to the Trilogy AB System.

This approval, along with the launch in June of the Durom® Acetabular Component for metal-on-metal articulation with Metasul® LDH(TM) Large Diameter Femoral Heads, greatly expands Zimmer's ability to offer alternate bearing options for hip replacement. The Durom/Metasul Large Diameter Head couple is designed to restore patient function by providing natural joint restoration, maximizing range of motion and reducing the potential for post- operative dislocation.

The Trilogy AB System is part of the Trilogy® Acetabular System, which was initially launched in 1994 and evolved from the successful Harris/Galante and HGP II Acetabular Cup System designs. According to Zimmer, the Trilogy Acetabular System is the world's largest selling family of acetabular products. The Company said 2005 revenue for Trilogy Acetabular Shells and associated liners was approximately $150 million.

The Company's Metasul bearing technology was first introduced in 1988 and, unlike competitive offerings, is a forged, high carbon cobalt-chromium alloy product. These characteristics have established the technology as the industry standard for strength and low metal-on-metal wear. The Trilogy AB femoral head and insert components are made of alumina ceramic and are designed to provide hard, wear-resistant articulating surfaces. Zimmer originally submitted its request for approval to market the Trilogy AB products in December 2004. The product has been sold outside the U.S. since 2001.
 

July 7^th: PuriCore Announces 510k Approval From FDA for VASHE(TM) Wound Cleansing System

PuriCore plc, the developer of a novel, safe technology that mimics the human body's natural anti-microbial, hypochlorous acid, today announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its proprietary VASHE(TM) Wound Cleansing System as a medical device.

The VASHE(TM) System produces a highly effective solution which is indicated for use in wound cleansing, irrigating, moistening and debriding acute and chronic dermal lesions. It will target indications such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

The VASHE(TM) System is based on existing patented and patent pending PuriCore technology and products that produce hypochlorous acid from the electrolysis of a saline solution from a table top or floor mounted system. It is the first wound cleansing system of its kind that can produce a solution on-site at the point of use by the clinician.

Earlier this year, results from a multi-year clinical study conducted at the University of Oxford in England were published in the Journal of Wound Care and presented at the Symposium of Advanced Wound Care in San Antonio, Texas and the Wound Healing Society Annual Meeting in Scottsdale, Arizona. Results from this study showed a positive and observable improvement in healing rates, pain reduction, effective wound debridement and cleansing action. PuriCore anticipates expanded clinical activities to further substantiate the VASHE(TM) System benefits and support additional regulatory approvals.
 

July 10^th: US Spine Announces Successful FDA Clearance for the Facet Fixation System
 

US Spine, an emerging leader in the development of innovative technologies for the treatment of human spinal disorders, is pleased to announce 510(k) clearance of the Facet Fixation System by the United States Food and Drug Administration.

The Facet Fixation System is a less-invasive alternative to pedicle screws as a means of creating a posterior tension band to support an Interbody fusion. The system consists of the Facet Gun, a disposable, pistol-like instrument, and the Facet Bolt, a three-piece implant that consists of a facet screw, a variable angle washer, and a locking nut.

Doris Blake, President of US Spine, said, "This is a significant milestone for our company. It's always exciting to witness the evolution of an idea, all the way through to a real product." Dr. Mark Falahee, the inventor of the Facet Fixation System, added, "The Facet Gun makes traditional spinal fusion much easier. The gun allows simple, reliable targeting and placement, by simply pulling the triggers. And the implant is more than just a facet screw, it's a bolt. Bolts are inherently stronger and more rigid, which is perfect for this application."

The company is positioning the Facet Fixation System as an alternative to pedicle screw fixation for one and two-level spine fusions, an estimated $600 million segment in the multi-billion dollar spinal implant market. US Spine plans to release the device in 3Q06, at the North American Spine Society annual meeting in Seattle, Washington. U.S. Spinal Technologies, LLC d/b/a US Spine: US Spine is a privately funded company developing innovative spinal products in collaboration with leading surgeons and scientists.

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