Archive for 2010

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:

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: 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