FDA approved products launched without a code

Secca(R) Therapy - An Effective and Minimally Invasive Option for Treating Bowel Incontinence - Launched in the US

GREENWICH, Conn., Aug. 31 /PRNewswire/ -- Mederi Therapeutics Inc. announces the US release of the Secca system for treatment of bowel incontinence. Secca Therapy is a minimally invasive procedure for a debilitating and embarrassing condition that affects tens of millions of Americans, both young and old. Secca therapy delivers radiofrequency (RF) energy to the muscles of the anal canal - tightening the muscles, producing better bowel control and reducing the symptoms of incontinence.

"This innovative treatment bridges the gap between often unsuccessful conservative measures, such as diet modification and biofeedback, and expensive and disfiguring surgical treatment," said Mederi CEO, Will Rutan. "The effect of bowel incontinence on quality of life is devastating, so the overwhelmingly positive response to the release of the Secca system is not surprising."

Secca therapy is an outpatient procedure that takes approximately 45 minutes and is performed in an endoscopy suite or ambulatory surgery unit, with the patient under general anesthesia or conscious sedation. Patients go home approximately one to two hours after the procedure and, typically, resume normal activities within several days. In clinical trials as many as 8 out of 10 patients had a positive clinical response to Secca therapy and showed significant improvement in quality of life scores. Further, recent clinical studies have shown symptom relief lasting as long as five years.

The dominant cause of bowel incontinence is damage to the pelvic floor during normal childbirth, thus, a significant majority of sufferers are women, seventy percent of whom are under the age of 65. In the elderly, bowel incontinence is cited as the second leading reason to institutionalize loved ones and over 45 percent of residents in nursing homes suffer from this condition.

Due to the embarrassment associated with bowel incontinence, studies report that fewer than one in five people with this condition have discussed it with their doctors. These factors indicate that bowel incontinence is both a well-guarded and under-reported illness.

 

FDA NEWS RELEASE
For Immediate Release: June 1, 2010
Media Inquiries: Elaine Gansz Bobo, 301.796.7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

“Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.
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No code, not getting reimbursed.

 

The Spanner™ Temporary Prostatic Stent - P060010
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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.


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Product Name: The Spanner™ Temporary Prostatic Stent
PMA Applicant: AbbeyMoor Medical, Inc.
Address:501 East Soo Street , Parkers Prairie, MN 56361
Approval Date: December 14, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060010a.pdf1

What is it? The Spanner™ temporary prostatic stent is a sterile, disposable device, positioned in the prostatic urethra from the bladder neck to the external urinary sphincter. The stent portion of The Spanner™ prevents collapse of the prostatic urethra and allows urine to drain from the bladder. The Spanner™ is held in position by a balloon in the bladder and by a soft anchor in the urethra.

How does it work? The Spanner™ is designed to facilitate urination following minimally invasive treatment for prostate enlargement, also called benign prostatic hyperplasia (BPH)2. Following these treatments, the prostate swells temporarily increasing obstruction requiring short-term catheterization (3-10 days). Following catheter removal the obstructive swelling may continue or worsen. The Spanner™ supports the prostatic urethra during the recovery period following removal of the initial catheter while allowing the patient to urinate normally. The appropriate Spanner™ size for the patient is determined using the Surveyor™ accessory device.

When is it used? The Spanner™ is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization.

What will it accomplish?In a clinical study, patients using The Spanner™ after removal of their catheters experienced a modest improvement in their lower urinary tract symptoms compared to patients who did not use The Spanner™ after removal of their catheters. Patients using The Spanner™ had less urine remaining in their bladders after voiding than patients who did not use The Spanner™. Adverse events with The Spanner™ were comparable to patients who did not use The Spanner™. The most common complaints that required treatment were bacteria in the urine, urinary tract infection, burning during urination, urinary retention, pain, urinary frequency, and device movement. Device movement or clot blockage can cause urinary retention in patients using The Spanner™.

When should it not be used? The Spanner™ stent should not be used in patients with a positive urine culture or active urinary tract infection, a history of symptomatic urinary tract disease that could affect the function of the stent, surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affects the function of the lower urinary tract, or a prostatic urethral length for which there is not an appropriately sized The Spanner™.