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J&J’s “NaviStar ThermoCool” Gets a Nod from FDA

admin — Fri, 06 Feb 2009 07:22:13 +0000

Washington, February 9:
Johnson and Johnson (JNJ) has finally got a green signal from The Food and Drug Administration (FDA), to market a device that could be a potential cure for the common heart-rhythm disorder called atrial fibrillation. This is the first ever approval given by the FDA for a device of this kind.
The news is welcomed by the already booming device market. As per the estimations made by JPMorgan analyst, Michael Weinstein the atrial-fibrillation market reached $1.6 billion in 2008 after growing by about 16 percent.
Daniel J. Starks, St. Jude’s chairman and chief executive, said at an investor conference on Friday, “Atrial fibrillation represents the best growth opportunity in medical devices here in the near term.”
As an instant reaction to the approval, the shares of J&J, which is a Dow Jones Industrial Average component, recorded a rise of 40 cents to reach $58.51 on Friday.
The device will be marketed by J&J’s Biosense Webster by the name “NaviStar ThermoCool” catheter and is expected to bring much relief for patients suffering from atrial fibrillation, who did not show a favorable response to treatment through drugs. Atrial fibrillation is a common rhythm disorder that presently affects about two million people in America.
People might suffer from an atrial fibrillation that occurs occasionally or the one that is persistent. Atrial fibrillation is a rhythm disorder that results into abnormally fast and disorderly beating in the heart’s upper chambers. This ailment is known to enhance the risk of strokes, heart failure and may lead to other complications if not addressed in time.
The device developed by Biosense Webster is capable of treating “paroxysmal” atrial fibrillation, a variation of atrial fibrillation where symptoms occur occasionally. This requires a treatment which involves making tiny burns that result into circular scars that can block the signals from the pulmonary veins.
FDA’s approval is based on the results of a clinical study of 167 patients. The study revealed that the device is effective in eliminating recurrence of atrial fibrillation episodes for one year in approximately 63 percent of treated patients in comparison to 17 percent of the patients who received drug treatment.
Biosense Webster happens to be the first device of its kind to get the official approval where competitors include big names like St. Jude Medical Inc. (STJ), Medtronic Inc. ( MDT) and Boston Scientific Corp. (BSX).
Until date patients suffering from the malady were subjected to drug treatment which usually failed to produce the desired results. Biosense Webster’s “NaviStar ThermoCool”catheter uses catheters inserted through a blood vessel and guided to the heart, to carry a radio-frequency current to burn, or ablate heart tissues associated with the ailment.
Even though this device is the first ever catheter for atrial fibrillation to be approved by the FDA, there are already plenty of devices already being used for the purpose. These devices had earlier been approved for some other purpose. Doctors have been using them in spite of a threat of scrutiny from federal authorities.

Kennewick General Hospital Gets Certificate of Need For Expansion

admin — Fri, 06 Feb 2009 06:11:40 +0000

KENNEWICK, Wash.– Kennewick General Hospital is one step closer to a future expansion.
The hospital got its certificate of need approved from the state. Now the hospital can apply for a loan from the Federal Housing Administration for more funding.
KGH leaders plan to build a new facility on the 40 acres of land known as the Southridge campus. The hospital’s CEO says having a new facility will also help our local job market.
“We’ll be creating a lot of construction jobs during the construction timeline but we’ve also estimated roughly about 100 new jobs fairly quickly will be created by the new project,” said Glen Marshall, Kennewick General Hospital CEO.
Other plans to raise money for the $113 project include taking money from the hospital’s cash reserves, selling property, and fundraising through the KGH foundation.

Women's health gets an examination

admin — Thu, 29 Jan 2009 05:35:48 +0000

With an eye to the future, Women’s Healthcare of Illinois hosted a free educational event at the Tinley Park Convention Center.
More than 100 people attending the event Saturday were instructed by four medical professionals on women’s health, ranging from bladder issues and office-based procedures to healthy pregnancies, genetics and ultrasounds.
Each of the four doctors, led by Dr. Kenneth Finkelstein, encouraged questions from the audience after the presentations.
“I learned quite a bit about health issues and women’s issues,” said Diane Gier, of Tinley Park. “It has been very interesting.”
Finkelstein, founder and CEO of Women’s Healthcare of Illinois, is a board certified obstetrician and gynecologist who specializes in urogynecology and pelvic prolapse. His vision for the near future includes expansion from his Evergreen Park facility into the southwest suburbs when groundbreaking is scheduled on a Mokena facility this spring.
“Hopefully, we’ll be able to begin work on the new facility in March. I think there are a lot of things that we talked about today, that many women in the Southwest suburbs haven’t had the benefit of in this area, in terms of new technology. That’s what we’re bringing here,” he said.
Tinley Park resident Doreen Kotwas and her friend, Florence Wolf, of Palos Heights, found the seminar both informative and interesting.
“My friend of 50 years suggested we come,” Kotwas said. “As you get older, you want to get to know as much as you can about your body.”
Wolf shared that she had a personal interest in the seminar.
“I do have a health problem and am very interested in the latest procedures. I’m very impressed today.”
Roseanna Smeraldo-Ali and husband, Zafar, had personal reasons for attending the seminar. Expecting a child in May, Smeraldo-Ali volunteered to have a four-dimensional ultrasound as a demonstration for the audience.
“My doctor at Women’s Healthcare, Dr. Butler, asked me to volunteer,” Smeraldo-Ali said. “And I agreed. I just want to see my baby.”
The demonstration, which drew “oohs” and “aahs” from the audience as images appeared, was monitored by Dr. Steven Ambrose, maternal-fetal medicine specialist.
“We are the only private group in our area with its own maternal-fetal medicine specialist and ultrasound facilities,” Finkelstein said.
Several pharmaceutical vendors, a healthy lunch and an opportunity to speak to the doctors rounded out the three-hour event.
“Our purpose here today was to introduce the different kinds of women’s issues that Women’s Healthcare of Illinois can help with,” said Iris Shaffer, public relations specialist. “Obviously, it has been of interest to the women out here because we have had an excellent turnout.”

Ex-OC payroll manager gets 5 years for embezzling

admin — Tue, 20 Jan 2009 21:42:22 +0000

SANTA ANA, Calif.—An ex-payroll manager who pleaded guilty to embezzling $487,000 from his Santa Ana employer has been sentenced to five years in prison.
Robert Lee Winn received the sentence in a Santa Ana court Tuesday, after pleading guilty last month to 48 felony counts of fraud and unauthorized computer access.
The 43-year-old Norco man used the payroll computer system of Advanced Medical Optics to make direct deposits into a business account for a company he owned.
Prosecutors say he then changed the payee’s name in the computer after the transactions were processed, making Advanced Medical employees responsible for taxes on money they never received.
Prosecutors say Winn spent the stolen money on personal luxuries and gambling.
Information from: The Orange County Register,

University of Minn. gets $50M hospital gift

admin — Sun, 04 Jan 2009 00:27:02 +0000

MINNEAPOLIS — The daughter of a pioneering medical device developer has pledged $50 million to the new children’s hospital being built at the University of Minnesota.
Caroline Amplatz pledged the money over 12 years to honor her father, Kurt Amplatz, a former radiology professor who holds more than 30 patents. Amplatz developed a number of non-invasive techniques, including a tiny device to repair a congenital heart defect that allowed thousands of patients to avoid open-heart surgery.
The university says the money is the second-largest gift from an individual donor. The hospital will be named University of Minnesota Amplatz Children’s Hospital.
Ground was broken for the new hospital last year, with completion scheduled by mid-2011. It’s part of Fairview Health Services.

Dyax gets FDA panel recommendation on drug

admin — Fri, 02 Jan 2009 17:13:54 +0000

Dyax Corp.
said Wednesday a Food and Drug Administration advisory panel recommended approval of the company’s developing treatment for a genetic condition that can lead to dangerous swelling.
The drug candidate is called DX-88 and is aimed at treating the condition called hereditary angioedema. While the FDA does not have to approve the drug, it usually follows the advice of its expert panels. The panel vote was slim, with six recommending approval and 5 recommending against approval. There were two abstentions.
DX-88 was already given priority review by the FDA in November and the agency set an action date for March 23. A priority review shortens the amount of review time from the standard 10 months to 6 months.
) closed unchanged at $2.98 in the regular session but gained 22 cents to $3.20 in after-hours trading when news on the vote was issued.
Copyright 2008 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed

Watson gets approval for mint-flavored Nicorette

admin — Thu, 11 Dec 2008 18:22:01 +0000

The Food and Drug Administration approved Watson Pharmaceuticals Inc.’s generic version of the nicotine gum Nicorette, the company said Wednesday, and Watson plans to start selling the mint-flavored gum in early January.
Watson said the FDA approved its over-the-counter nicotine polacrilex gum in 2 mg and 4 mg strengths. Nicorette is made by British drug maker GlaxoSmithKline PLC, and sold by Johnson & Johnson Healthcare. The FDA approved Nicorette in February 1996, and the gum is available in six flavors.
Perrigo Co. also makes a generic version of fruit-flavored Nicorette.
Watson said the total market for over-the-counter nicotine gum reached more than $300 million in the year ended September 2008.
Copyright 2008 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed

An invitation to fix health care system gets crowds

admin — Thu, 11 Dec 2008 01:54:38 +0000

Business executive Roger Vang wanted to know what federal plans might affect his company’s health insurance plan so he checked President-elect Barack Obama’s website.
“I wanted to see if Obama had any major changes coming,” said Vang, chief financial officer of Diversified Plastics in Brooklyn Park. “They had a button to click for information on health care, so I foolishly did.”
The button led Vang to a discussion guide for a grass-roots forum to help modernize the nation’s health care system. It invited him or anyone else to host a local forum. So he did.
The forum and others in Minneapolis and St. Paul were among thousands held across the nation last month in response to Obama’s health transition team’s request on his
website. The website outlines health care problems and provides discussion questions. Moderators are asked to e-mail feedback and suggestions from the public meetings to the team, led by Health and Human Services Secretary-designate Tom Daschle.
Daschle attended some forums, including one in Dublin, Ind. He told 35 people there that the forums are designed “to hear directly from you about your concerns, about your recommendations, about ways you think our system can be made to work better,” the Washington Post reported.
Vang was surprised by the quick response after he e-mailed invitations to members of the local Chamber of Commerce and a manufacturing group. Within 36 hours, 27 people signed up and a dozen more wanted to, but he didn’t have room.
“So many came that I had to confiscate the plant lunch room,” the company’s largest meeting space, Vang said. Only a few failed to show the morning of Dec. 30, despite a nasty snowstorm.
“They apparently wanted to talk,” Vang said. “There was quite a range of opinions. … We passed around the mike so we could hear everybody.”
Vang guided the discussion, took notes and e-mailed a summary back to Obama’s health transition team.

StemCells gets FDA approval for clinical trial

admin — Tue, 09 Dec 2008 18:27:21 +0000

has received approval from the Food and Drug Administration to begin a clinical trial of a product candidate to treat Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that affects mainly young children.
Palo Alto-based StemCells (NASDAQ: STEM) designed the Phase 1 trial to evaluate the safety and efficacy of its HuCNS-SC product candidate cells as a treatment for PMD. Currently, there are no approved treatments for this disease, the company said.
This is StemCells second FDA approval for a clinical trial to evaluate the candidate cells as a potential treatment for neurodegenerative diseases. It has also received approval for a Phase I clinical trial to treat neuronal ceroid lipofuscinoses (NCL), or Batten disease. That trial is scheduled to be completed in January.
For the new trial the company has begun seeking approval by the Investigational Review Board of potential clinical trial sites, to begin enrolling patients.

WHO GETS WHAT: Billions for health care insurance

admin — Wed, 03 Dec 2008 06:36:49 +0000

WASHINGTON (AP) — It will get vastly cheaper for most people to keep health insurance after losing a job if the government’s stimulus plan becomes law. Some nickel and dime cuts in health coverage for the poor will be reversed, too. Geek jobs in medicine will grow.
The billions to be poured into health care from the economic stimulus package will do little if anything about the chronic conditions behind the nation’s stubbornly large ranks of uninsured.
Instead the plan is a temporary lifeline, hasty measures for nearly desperate times.
Jobs aren’t the central point of the package sought by President Barack Obama, passed by the House and steered to the Senate.
The point is to cushion the blow from losing one.
For those who qualify, relief would be substantial.
Under a dramatic, temporary expansion of COBRA, the law that lets the unemployed keep health insurance from their old job for up to 18 months if they pay for it in full, costs would drop by about two-thirds for a year.
Moreover, people who lose a job they’ve had for 10 years could stay on COBRA at their expense all the way to age 65, when Medicare takes over, if they don’t get another job with insurance first. People 55 and over could do the same without meeting the 10-year requirement.
It’s so expensive for people to extend that insurance now that many don’t do it. It can quickly eat up a majority of unemployment benefits.
That’s just one of the steps to maintain health access in the worst economic conditions Americans have lived through in generations. And that’s the key — maintenance more than advancement.
People who lose jobs at businesses that employ fewer than 20 people don’t qualify for COBRA. For them, the government would bring many more jobless people under Medicaid’s wing. The feds would pay for this, plus give states much more money to run cost-shared part of the program.
In return, states taking the extra money would have to back down on some of the cuts they’ve made to the program recently.
Altogether it’s a pricey lifeline: $40 billion to subsidize health insurance for the unemployed and more than twice that to support Medicaid.
Budget hawks, whose voices are practically lost in the wind these days, wonder whether the relief really will be temporary. They know it’s politically tough for the government to take something back once people get a taste of it.
Witness the expiring tax cuts that former President George W. Bush won from Congress. Obama promised to continue most of those cuts while raising taxes back up on the rich. But with the recession so deep, it’s less likely he’ll seek to raise those tax rates after all.
The recovery plan also sets aside $20 billion for medical record-keeping, a sum likely to grow jobs in information technology.
Four in five doctors still rely on old-fashioned paper files. Digital records are bound to cut administrative costs and improve care by making it easy to share patient information. But conversion is a huge task, for which Obama wants to spend $50 billion over five years.
The economic recovery plan isn’t the only game in town when it comes to health care, although it’s the most expensive. The Senate has voted to extend government-sponsored health insurance to about 4 million of the estimated 9 million uninsured children. The House acts on that next.
Associated Press writers Kevin Freking and Ricardo Alonso-Zaldivar contributed to this report.