Archive for June, 2010

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

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

04.06.2010 blog, FDA Approved No Comments

Asthmatx, Inc. Alair Bronchial Thermoplasty

Photo of Alair Bronchial Thermoplasty 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: Alair Bronchial Thermoplasty System
PMA Applicant: Asthmatx, Inc.
Address: 888 Ross Drive, Suite 100 Sunnyvale, CA 94089
Approval Date: April 27, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032a.pdf

What is it?
The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy. read more

04.06.2010 blog, FDA Approved No Comments

Esteem Implantable Hearing System

photo of Esteem® Implantable Hearing System- P09018

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: Esteem®
PMA Applicant: Envoy Medical Corporation
Address: 5000 Township Parkway, St. Paul, MN 55110
Approval Date: March 17, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/P090018a.pdf

What is it?
The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and external testing and programming instruments. read more