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28.07.2011 blog 4 Comments

FDA Approves Hepatitis C drugs.

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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.

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

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

04.06.2010 blog, FDA Approved 1 Comment

Thoratec HeartMate II LVAS

Picture of a Thoratec HeartMate II LVASThis is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

What is it? The HeartMate II LVAS is a left ventricular assist device (LVAD) system, which is a device that helps the heart’s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes a pump implanted inside the patient’s body and components that remain outside the patient’s body. The pump controller and batteries are worn outside the patient’s body. The system also includes a battery charger/power supply and monitor that remain outside the body. read more

04.06.2010 blog, FDA Approved No Comments

Medtronic Melody® Transcatheter Pulmonary Valve

Picture of the device.

FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Medtronic Melody® Transcatheter Pulmonary Valve (Model PB10) and Medtronic Ensemble® Transcatheter Valve Delivery System (NU10)
Manufacturer: Medtronic Heart Valves, Inc.
Address: 1851 Deere Avenue , Santa Ana, California 92705
Approval Date: 25 January 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/H080002a.pdf

What is it?
The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. The Melody valve is made from a cow’s jugular vein valve that is sewn into a small metal stent (scaffolding). The Melody valve comes in sizes 18, 20, and 22mm diameters and has a stent length of 28mm. The Medtronic Ensemble® Transcatheter Valve Delivery System is a catheter (long tube with small diameter) that helps guide the Melody into the heart. The Ensemble delivery system has catheters with balloon sizes of 18, 20, and 22mm. read more

04.06.2010 blog, FDA Approved No Comments

Express® LD Iliac Premounted Stent System

Photo of Express® LD Iliac Premounted Stent SystemThis is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Express® LD Iliac Premounted Stent System
Manufacturer: Boston Scientific Corporation
Address: One Boston Scientific Place, Natick, MA  01760
Approval Date: March 5, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090003a.pdf

What is it?
The Express® LD Iliac Stent is an expandable, mesh-like stainless steel tube.  The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter.  The Express LD Iliac Stent acts like a support (scaffold) by holding open an artery in the pelvis or legs (iliac artery) to maintain adequate blood flow to the legs. read more

04.06.2010 blog, FDA Approved No Comments

Medtronic Vascular Complete® SE Vascular Stent System

Picture of Complete® SE Vascular Stent System

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval

Product Name: Complete® SE Vascular Stent System (20-100mm lengths)
Manufacturer: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: March 17, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090006a.pdf

What is it?
The Complete SE Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries).  It consists of two parts, the stent and the delivery system.  The stent is an implant constructed of a nickel-titanium alloy (nitinol) tubing and laser-cut into a mesh shape.  The stent is mounted within a long, thin, tube-like device called the delivery catheter. read more

04.06.2010 blog, FDA Approved No Comments

Quick-Close® Vascular Suturing System

Picture of a Quick-Close® Suture Applier.
Quick-Close® Suture Applier
Picture of a Quick-Ti® Cinch Applier.
Quick-Ti® Cinch Applier

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Quick-Close® Vascular Suturing System
PMA Applicant: Interventional Therapies, LLC
Address: 1 Gorham Island, Westport, CT 06880
Approval Date: April 8, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080029a.pdf

What is it?
The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The Suture Applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester [Novafil] ™) fitted with stainless steel rings. The Cinch Applier has a syringe-type shape with an extended handle. read more

04.06.2010 blog, FDA Approved No Comments

Softec HD Aspheric Posterior Chamber Intraocular Lens

Image of a Softec HD Aspheric Posterior Chamber Intraocular Lens.This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Softec HD Aspheric Posterior Chamber Intraocular Lens
PMA Applicant: Lenstec, Inc.
Address: 1765 Commerce Ave N, St. Petersburg, Florida 33716
Approval Date: April 12, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/P090022a.pdf

What is it?
The Softec HD posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery.Exit Disclaimer A cataract is a gradual thickening, hardening and clouding of the eye’s lens, resulting in loss of vision. Cataracts are often the result of aging, but can have other causes. read more