04.06.2010
blog, FDA Approved
Quick-Close® Suture 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
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.
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
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: 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
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
03.05.2010
blog
The pace of new technology in surgery is astounding. Just yesterday learning open surgery skills took many years to perfect. Now with minimally invasive surgery, there is a new skill set to learn and to master. Tomorrow is here today, “Robotic Surgery” is even a more advanced skill set that will allow for greater dexterity and skill for the surgeon. Patients benefit tremendously because with these advances, the ability for improved precision in surgery and better results is a significant benefit.
I remember training at Stanford in gynecologic surgery, it was a great enigma. Sitting at the end of the operating table, holding a retractor as a resident. I was the “third or fourth” surgical assist. I could not really see anything, there were so many bodies huddled around the operating table. I would begin to fall asleep because I had been up all night long on-call. I thought, this is no way to learn. I can’t see anything. But since those days of sleepless nights and frustration, I came out a pretty great surgeon. Learning minimally invasive techniques that have spared many patients from excess pain and disability. Truly remarkable surgery, allowing patients to go home that day or the next.
I am in favor of the rapid progress of these new surgical technologies, and I am very excited that surgeons all over the world are sharing videos and techniques. MDV1 is an agency for innovating physicians and surgeons consulting the BioDevice Space. If you have any questions, please contact us phone: 408-309-8457
19.01.2010
news
News from the Wall Street Journal on a novel new minimally invasive device that treats fibroids in women.
Of all the pains and indignities the female body suffers, some of the most common are uterine fibroids—benign tissue growths in the womb. It’s estimated that as many as 70% of women develop them at some point. Most are asymptomatic and women never know they’re there. But in about one-third of cases—even more among African-American women—the fibroids become large enough to cause pain in the back, abdomen and pelvis, bloating and very heavy menstrual bleeding. Some grow to be as large as a grapefruit and can interfere with other organs.
The standard treatment is a hysterectomy, which permanently removes the uterus along with the fibroids. More than 200,000 hysterectomies are performed in the U.S. each year for fibroids; it’s the second most common surgical procedure for women, after Cesarean sections. read more
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