28.07.2011 blog 4 Comments

FDA Approves Hepatitis C drugs.


Much Better Hepatitis C Cure Rate When Incivek Added to Standard Combination Therapy
By Daniel J. DeNoon
WebMD Health News Reviewed by Laura J. Martin, MD

May 23, 2011 — The FDA has approved Vertex’s Incivek as an add-on to current interferon/ribavirin therapy for hepatitis C infection.
Like Victrelis, also approved this month, Incivek greatly boosts the chances that hepatitis C treatment will result in a cure — that is, a “sustained viral response” or SVR. Although hepatitis C virus (HCV) may not be totally eliminated, an SVR essentially means a person will never have to worry about developing complications of hepatitis C disease.
Standard treatment with interferon and ribavirin lasts 48 weeks, yet results in an SVR for fewer than half of patients. In clinical trials, adding Incivek to this regimen boosted SVR rates 20% to 45%.
Moreover, most patients taking Incivek will have to tolerate the side effects of the triple combination therapy for only 24 weeks.
Earlier this month, an FDA advisory panel enthusiastically recommended approval of Incivek and Victrelis.
Incivek and Victrelis both target the HCV protease enzyme, making it nearly impossible for the virus to replicate. Although the virus quickly becomes resistant to either drug used alone, combination therapy with interferon and ribavirin keeps HCV in check.
“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” Edward Cox, MD, MPH, director of the FDA’s office of antimicrobial products, says in a news release.
Incivek and Victrelis increase the already difficult side effects of standard therapy — particularly anemia — but they do not have to be taken for the full 48 weeks of standard therapy. And there’s evidence that patients who have a strong early response to the drugs may be able to shorten the grueling course of treatment.
Incivek is given for the first 12 weeks of combination treatment. Interferon/ribavirin treatment lasts a total of 48 weeks, although early responders may be able to stop at 24 weeks.
Incivek has two major side effects: It increases the anemia seen with interferon/ribavirin, and it causes an itchy rash in more than half of patients. Other side effects include nausea, fatigue, headache, diarrhea, and anal or rectal irritation and pain.
The clinical trials that led to the Incivek reported somewhat higher cure rates than the trials that led to Victrelis’ approval. But the two drugs have never been tested head to head, so it’s impossible to say for sure whether one works better than the other.
A major marketing battle is expected between Merck and Vertex. Although each of the drugs is a major advance over current hepatitis C therapy, even better treatments are in the pipeline.
New polymerase inhibitors promise to make combination treatment even more effective — and may even allow some patients to avoid the interferon/ribavirin combination. But such drugs are at least three years away from the marketplace.

22.06.2011 FDA Approved No Comments

Pain Relief for Anal Fissures

FDA Approves New Drug for Chronic Anal Fissure Pain
Mark Crane
Authors and Disclosures
June 22, 2011 — The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.

The ointment will be the only FDA-approved prescription product for patients with this condition, according to the company. Marketed under the name Rectogesic, the ointment is already approved in the European Union and has been outlicensed outside Europe by ProStrakan to commercial partners in 34 countries worldwide.

“The pain associated with anal fissures can be unrelenting and debilitating. Prompt initiation of treatment by primary care practitioners, gynecologists, gastroenterologists and surgeons alike is critical to a patient’s wellbeing,” Scott Berry, MD, colorectal surgeon and the principal investigator on one of Rectiv’s clinical trials, said in a news release. “Now we have an effective and easy-to-use topical ointment which allows grateful patients to resume their daily lives.”

Approximately 700,000 people in the United States receive a diagnosis of or treatment for an episode of anal fissures each year. An anal fissure is a small tear in the skin that lines the anus, and it can occur in many ways, such as passing large or hard stools, straining during a bowel movement, or following an episode of diarrhea. When an anal fissure occurs, it typically causes severe pain and bleeding with bowel movements. Chronic anal fissure has been shown to significantly affect patients’ quality of life, the company said. An episode can take 6 to 8 weeks to heal, and if healing does not occur surgery may be required.

ProStrakan expects Rectiv to be available in the United States in the first quarter of 2012.

ProStrakan, based in Galashiels, Scotland, and Bedminster, New Jersey, is a subsidiary of Kyowa Hakko Kirin Co. Ltd., a Japan-based global specialty pharmaceutical company.

Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.

18.12.2010 Uncategorized No Comments

FDA approves Cryoballoon Ablation for PAT.

Medtronic Receives FDA Approval for First and Only Cryoballoon Ablation Treatment in the U.S. for Paroxysmal Atrial Fibrillation

New Arctic Front® Cardiac CryoAblation Catheter System Reduces Symptoms for Patients with Common Heart Rhythm Disorder

MINNEAPOLIS – December 17, 2010 – Medtronic, Inc. (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved its Arctic Front® Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

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17.12.2010 news 1 Comment

FDA revokes Avastin approval for breast cancer.

Genentech imageWASHINGTON (AFP) The US Food and Drug Administration said Thursday that Avastin is not an effective treatment for breast cancer and said it would take steps to revoke market approval and change the drug’s label.

Acting on the advice of an expert panel earlier this year, the FDA said the drug, also known as bevacizumab, carries risks such as severehigh blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer.

Meanwhile, European experts urged restricting the drug’s use to be combined with just one type of chemotherapy, instead of with several as is the current practice.

The FDA “is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use,” it said in a statement.

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15.11.2010 Uncategorized No Comments

Spineview Provides Future Discectomy Device.

Spineview introduces the enSpire Discectomy and Decortication device. This device provides a new technology for easier discectomy, smaller incision, and faster patient recovery. The device comes as a disposable battery operated and self contained device that cuts and removes spinal disc annular tissue simultaneously. The device allows the surgeon a novel approach with a more intelligent approach.


15.11.2010 Uncategorized No Comments

Airstrip OB

Airstrip technologies (http://airstriptech.con) is a medical software company that has developed a platform for delivering critical information to mobile devices. Their first product Airstrip OB delivers fetal monitor strip information directly to the ob/gyn physician’s mobile device. They deliver to iPhone and iPad and the value is significant for both mother and baby. While a woman is in labor, the fetal monitor strip shows critical information regarding the health of the fetus during labor. Up until now, the doctor had to communicate with the nurse and get a second hand report on the monitor strip. Now, the monitor tracing and data is viewed instantly by the doctor. The patient feels reassured that she is not alone, the ob/gyn is viewing her progress even though he/she is not at her bedside.

This is a significant advance that creates a new kind of physician, one that is more informed and able to react to critical life changing events. Airstrip OB is a wonderful new technology that makes the doctor and hospital top notch providers of the best medical care. Airstrip technologies, way to go!

04.08.2010 blog, news No Comments

FDA Medical Device Regs Updated

Medtronic, Stryker, J&J Face New U.S. Rules for Medical Device Approvals
By David Olmos and Sophia Yan – Aug 3, 2010 9:01 PM PT

Medical device makers Medtronic Inc., Johnson & Johnson and Stryker Corp. face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.

The Food and Drug Administration released the proposed new requirements for the so-called 510(k) program that covers products similar to previously approved devices, or about 90 percent of products cleared for sale.

Medical device companies say the 510(k) process is rife with delays and inconsistent requirements, while consumer advocates say patients are at risk because of inadequate safety rules. The new proposals address both issues, giving device makers a more predictable process while insisting they provide more safety data, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. read more

02.08.2010 blog, HITECH MU No Comments

LifeMed ID Smart Cards Enhance “Meaningful Use”

Life Med ID is the leading Smart Card USA provider for securing patient ID and access to electronic medical records.  The system is the latest technology that can help hospitals and integrated medical groups to meet the new HITECH act “meaningful use” guidelines.  The system is a web based system that integrated to other EMR systems to aggregate the patient’s medical records into a single holistic medical record system.

Current implementations of the system have yielded patient benefits in faster registration at the admit station for the hospitals and clinics.  Patient wait times have decreased from 18 minutes to 3 minutes, a significant improvement in initial encounters and satisfaction.  Life Med also has self-service kiosks that can be deployed in the lobby of facilities that can read the smart cards, and help patients with encounter forms and registration.  Patients can also login to view their own medical information with a web browser.  In emergencies, EMT personell can have satellite connected smart card readers to view critical patient medical information. read more

05.06.2010 news No Comments

Parma hospital part of settlement in heart device kickback scheme

By Peter Krouse, The Plain Dealer June 04, 2010, 11:39AM

PARMA, Ohio — Parma Community General Hospital must pay part of a $3.9 million settlement that resolves civil allegations that St. Jude Medical Inc. paid illegal kickbacks to two hospitals to secure heart-device business, the U.S. Justice Department announced Friday.

The kickbacks represented improper rebates paid to Parma Community General and Norton Healthcare of Louisville, Ky., according to the Justice Department.

St. Jude, based in St. Paul, Minn., will pay $3.725 million under the settlement, Parma Community General will pay $40,000 and Norton Healthcare will pay $133,000

The investigation was initiated by a whistleblower named Jerry Hudson who worked for St. Jude. He received $640,050 as part of the settlement, the Justice Department stated. read more

04.06.2010 blog, FDA Approved No Comments

ProGEL™ Pleural Air Leak Sealant

Product name: ProGEL™ Pleural Air Leak Sealant
PMA Applicant: NeoMend, Inc
Address: 60 Technology Dr., Irvine, CA 92618
Approval Date: January 14, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010047a.pdf

What is it?
The ProGEL™ Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure techniques, (that is, sutures or staples) for open resection of lung tissue. read more