Industry News
August 8 – August 13, 2005
Aug 12th: Medical Ventures Receives U.S. FDA 510(k) Clearance for
the Angiometrx Metricath Gemini(TM) Balloon Catheter for Peripheral
Arteries
Medical Ventures Corporation, a medical technology company
specializing in the development and commercialization of
cardiovascular medical devices, is pleased to announce that its
Angiometrx division has received U.S. FDA 510(k) clearance for the
Metricath Gemini Balloon Catheter for peripheral artery procedures,
which is required for Angiometrx and its U.S. distributor to begin
selling and marketing the Metricath Gemini Balloon Catheter in the
United States.
The Metricath Gemini may be used by clinicians whose patients who
have been diagnosed with peripheral arterial disease (PAD), which is
caused by a fatty build-up in the artery that blocks normal blood
flow. The peripheral arteries supply blood to extremities and
organs; including, the kidneys, liver, arms, legs and feet. There
are approximately 400,000 peripheral interventional procedures in
the U.S. yearly.
Aug 12th: Stryker Announces Exclusive Distribution Agreement to
Enter Hip Resurfacing Market
Stryker Corporation announced today that the Company has entered
into an exclusive U.S. marketing and distribution agreement with
Corin Group PLC (London Stock Exchange: CRG), a leading United
Kingdom-based manufacturer and supplier of orthopaedic devices, for
the Cormet Hip Resurfacing System and Optimom, its large diameter
articulation hip system.
The ten-year agreement should enable Stryker to be one of the first
companies to offer hip resurfacing technology to patients in the
United States.
Interest in hip resurfacing procedures is on the rise globally due
to the bone conserving nature of the procedure and anticipated
benefits related to post-operative activities and range of motion.
Aug 12th: "Breakthrough" For Scientists Hunting AIDS Cure
Scientists announced for the first time that they could be nearing a
cure for Aids, which has already claimed 25 million lives worldwide.
A decade after the development of a therapeutic drug cocktail which
transformed Aids from a killer infection to a chronic disease,
doctors said yesterday that they may have made the next big
breakthrough. Aids is unique among infectious diseases because even
after treatment with a cocktail of powerful drugs, "latent" virus
remains hidden in the body's DNA and erupts as soon as treatment
stops. The scientists found that combining a cheap drug called
valproic acid with the existing therapeutic cocktail, the level of
"latent" HIV fell dramatically. They claim they may be able to
eliminate the latent HIV altogether, curing the disease.
Aug 11th: Pfizer Sets Guidelines on Its Advertising; Adds More
Risk Information
Pfizer Inc. pledged Thursday not to advertise new medicines directly
to consumers for at least six months and only to promote its
impotency treatment Viagra on TV to predominantly adult audiences.
The promises are part of a package of advertising changes the
world's largest drug company adopted as criticism of the way
medicines are promoted to patients mounts. Pfizer's move follows
last week's announcement by the pharmaceutical industry of new
advertising guidelines designed to better communicate benefits and
risks of drugs to patients.
Aug 10th: Medtronic Announces FDA Approval of Real-Time Continuous
Glucose Monitoring System
Medtronic announced the U.S. Food and Drug Administration approval
of the Guardian RT Continuous Glucose Monitoring System for improved
diabetes management.
Medtronic noted that the system displays real-time glucose values
every five minutes and alerts patients when glucose levels become
too high or too low. Prior to broad distribution, the company will
initiate a limited market release in select U.S. cities to further
evaluate training, education and reimbursement needs.
Aug 10th: Researchers Discover New Tumor Defense System
Researchers have discovered that tumors release fatty acids that
interfere with the cells that are trying to kill them. Consequently,
strategies that reduce the amount of fatty acids surrounding the
tumors may give a boost to anti-cancer therapeutics. The details of
these findings appear in the September issue of the Journal of Lipid
Research, an American Society for Biochemistry and Molecular Biology
journal.
Aug 9th: Boston Scientific To Loan Celsion Corporation Up To $15
Million
Celsion Corporation today announced that it had reached an agreement
pursuant to which Boston Scientific Corporation (NYSE:BSX) will lend
Celsion up to $15 million. The loan, which has a term expiring on
February 20, 2009, will be disbursed in up to three installments and
will bear interest at a rate of prime plus 1 percent. The funding of
the second and third installments of the loan is subject to Boston
Scientific's reasonable satisfaction with the continuing development
of the Prolieve(TM) System. Celsion has the right to prepay the loan
at any time and Boston Scientific may apply the outstanding
principle plus accrued interest against the purchase price of the
Prolieve assets or convert the outstanding principle plus accrued
interest into shares of Celsion common stock at a minimum conversion
price of $0.61 per share. In conjunction with the agreement the
purchase price for Boston Scientific's option to purchase Celsion's
Prolieve assets has been fixed at $60 million.
Aug 9th: Drug Makers Object To U.S. Plan For Early Warnings
Plans by U.S. regulators to release preliminary information about
potential drug side effects could lead to unnecessary confusion and
"irrational fears" about medicines, drug makers said on Monday. The
Food and Drug Administration (FDA) has proposed a "Drug Watch" Web
page that would list drug safety concerns that are being evaluated
by the agency. The drug industry's U.S. lobbying group said the
information the FDA was aiming to publicize "is too vague and
preliminary to be of any value in making informed treatment and
prescribing decisions." "Such information is ... not likely to
accomplish anything other than confusion among physicians and the
public and creation of irrational fears about the safety of drugs on
the list," the Pharmaceutical Research and Manufacturers of America
(PhRMA) said in written comments to the FDA. Releasing early
information may violate a law requiring data released by federal
agencies to be useful, PhRMA argued. It also said the plan may
exceed the FDA's authority.
Aug 8th: Kodak announces new medical imaging solutions; Debuts
information system for outpatient imaging centers systems offer
faster, more accurate results for patients
Eastman Kodak Company introduced new medical imaging and information
systems designed to enhance efficiency and improve patient care by
offering faster, more accurate diagnostic results.
The new products, unveiled this week at the annual meeting of
American Healthcare Radiology Administrators, include a digital
imaging system and software that improves image analysis and
information management.
The introduction of these new products comes at a time when
healthcare facilities are replacing traditional x-ray film with
digital imaging systems that provide enhanced image quality and
flexibility.
Aug 8th: Philips Completes Acquisition of Stentor
Philips Medical Systems, a division of Royal Philips Electronics
announced that it has completed the acquisition of a 100% stake in
Stentor Inc. On July 6, 2005, Philips first announced its intention
to acquire Stentor, a leader in the distribution, management, and
storage of digital medical images. The acquisition is designed to
strengthen Philips position as a primary supplier of technology to
the Healthcare Information Technology (IT) market. As a result of
this acquisition, Philips now ranks globally as the number 2
supplier of picture archive and communications systems (PACS).
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