New Products

October 1, 2003



 

NEW PRODUCTS

Listings are for information only and do not constitute endorsements.

Jump to:Choose article section...FDA approves Seasonale: first extended-cycle OCQuick new surgical option for urinary incontinence Bone sonometer for office-based osteoporosis monitoring Helping women "get a grip" during childbirth Disposable fetal monitoring straps A recovery plan for postpartum depression Mesh support product for pelvic floor repair Cushioning the pain of spot compression mammography FDA approves DNAwithPap for screening women > age 30 Office-based digital U/S system with real-time 3D imaging

FDA approves Seasonale: first extended-cycle OC

The Food and Drug Administration has just approved Seasonale (levonorgestrel and ethinyl estradiol [EE]), an extended-cycle oral contraceptive designed to reduce the number of periods women have from 13 to four per year (one each season), according to an announcement by Barr Laboratories, Inc. (Woodcliff Lake, N.J.). A nontraditional 91-day regimen taken daily as 84 active tablets of 0.15 mg of levonorgestrel/0.03 mg of EE, followed by seven inactive tablets, Seasonale provides an alternative to the traditional 28-day program.

Clinical data supporting the approval came from a randomized, open-label, multicenter trial and an extension to that trial, in which the product was found to prevent pregnancy and have a comparable safety profile to traditional OCs. For more information on Seasonale, which will be available by prescription at the end of October, visit the Web site, http://www.seasonale.com . Another manufacturer-sponsored Web site aimed at educating patients is http://www.knowyourperiod.com .

Quick new surgical option for urinary incontinence

The newly FDA-approved Monarc subfascial hammock procedure, a minimally invasive surgical approach to curing female urinary incontinence that's already available in several European countries, was recently introduced in the United States. The company recommends that physicians receive either cadaver or preceptor training on the new procedure. Interested physicians should contact their local sales representative at 800-328-3881. With the Monarc approach, surgeons introduce a supportive mesh subfascially, using proprietary helical needles for precise placement of the mesh, during a short outpatient procedure, according to the manufacturer, American Medical Systems Holdings, Inc. The Minneapolis-based company also offers three other minimally invasive products to treat urinary incontinence: SPARC, In-Fast Ultra, and the Artificial Urinary Sphincter.

For more information, visit the company's Web site at http//www.AmericanMedicalSystems.com .

Bone sonometer for office-based osteoporosis monitoring

The new Sunlight Omnisense line of bone densitometry units are the only bone sonometers available that can measure bone density at multiple skeletal sites, according to the distributor, Wallach Surgical Devices (Orange, Conn.).

The ultrasound technology of the Omnisense 7000S—and its mobile counterpart, the 8000S—are said to eliminate soft-tissue effects, achieving greater accuracy in office-based diagnosis and monitoring of osteoporosis. Both products are noninvasive and offer a radiation-free alternative. For more information, call Wallach Surgical Devices at 800-243-2463 or visit the company's Web site at http://www.wallach surgical.com .

Helping women "get a grip" during childbirth

The PushPal Birthing Aid is a device meant to aid patients during the second stage of labor as they assume the popular semi-lithotomy position and get ready to push. Designed by an obstetrician, it works by wrapping around each of the patient's legs (as you would wear a leg weight) and fastening with Velcro strips to provide leverage and a comfortable grip for pulling the woman's knees toward her shoulders. Contraindications include joint problems of the knee or hip, an artificial knee or hip joint, a history of thrombophlebitis or severe varicose veins of the lower leg, or lower-leg skin disease.

A small pilot study of 199 patients at Pomona Valley Hospital Medical Center (Pomona, Calif.) assessed via patient questionnaire whether women found it effective or not in helping their pushing efforts. According to its inventor, Ju C. Rhee, MD, a practicing OB at Pomona, 93% of the women found PushPal helpful. He claims that the aid also seemed to shorten the second stage of labor by an average of 12.7 minutes in the subgroup of women having their second baby. The product is also available in a large size for women with a calf circumference of 18 inches or more.

For more information, visit http://www.pushpal.com , or call 1-866-254-6489.

Disposable fetal monitoring straps

Precision Dynamics Corporation offers Securline Disposable Fetal Monitoring Abdominal Straps, used to secure external monitoring devices to a patient during labor. The straps, which come in pairs (one blue, one pink) are available in two styles: the buttonhole-style strap for the pin-type monitor and the VELCRO hook and loop fastener, intended for monitors that are configured like a watch. The products are inexpensive and single-use, preventing the potential spread of pathogens, according to the San Fernando, Calif.-based company. For more information, call 800-772-1122 or visit the company's Web site at http//www.pdcorp.com .

A recovery plan for postpartum depression

Conquering Postpartum Depression: A Proven Plan for Recovery aims to speed the recovery not only of the 400,000 new mothers each year said to suffer from that condition, but also the eight out of 10 women who experience some degree of mood alteration before and after childbirth, according to its authors. Co-authors Ronald Rosenberg, MD, who is both an ob/gyn and a psychiatrist, Deborah Greening, PhD, a clinical psychologist, and James Windell, MA, a family therapist, present a treatment plan that taps their various disciplines. They also say this is the first book to explore genetic factors and markers that can predict which patients are prone to depression so preventive measures—like prescribing antidepressants during pregnancy and breastfeeding—can be taken. For more information, visit the publisher's Web site at http://www.perseuspublishing.com .

Mesh support product for pelvic floor repair

The first polypropylene mesh support material for female pelvic floor repair, GYNEMESH PS, is now available from GYNECARE, a division of Ethicon (Somerville, N.J.). The lightweight material offers permanent support for cystocele and rectocele repair and vaginal vault suspension.

Constructed of the same material as PROLENE polypropylene suture, the product's design makes it 70% more flexible than standard mesh, according to the manufacturer. The knitted construction permits the mesh to be cut into different sizes and shapes without unraveling. For more information, contact the toll-free customer support center at 1-877-ETHICON or visit http://www.gynecare.com .

Cushioning the pain of spot compression mammography

The maker of a product designed to cushion the pain of routine screening mammography (MammoPad) has a new product specifically for women undergoing subsequent diagnostic spot compression views. The Spot Compression MammoPad, which comes in four sizes and shapes, aims to ease the pain of detailed follow-up imaging performed after an area of concern is identified, according to BioLucent, Inc. (Aliso Viejo, Calif.). The latter procedures are often more painful because greater breast compression is required and the smaller-sized compression paddle can pinch a woman's skin and breast tissue, the company says. The product is said to be most effective when applied to the spot compression paddle and used in tandem with a standard MammoPad.

For more information about the MammoPad breast cushion, call (toll-free) 866-460-4141 or visit http://www.MammoPad.com .

FDA approves DNAwithPap for screening women > age 30

Digene Corporation's High-Risk (HR) HPV DNA Test has received FDA approval for a new indication—as a screening test in conjunction with the Pap test for human papillomavirus infection in women aged 30 or older, according to the Gaithersburg, Md.-based manufacturer of the test. The renamed DNAwithPap combines the Hybrid Capture 2 HPV DNA test for HPV with a routine Pap test to improve sensitivity in screening for cervical cancer.

The new test aims to help physicians determine which patients are at extremely low risk for cervical cancer versus those who may need to be monitored more closely. According to studies, the testing combo provides a very high certainty that a woman with a normal Pap result who is HPV-negative is at low risk for high-grade cervical disease or cancer in the near term. The hc2 HR HPV DNA Test, which detects the 13 key cancer-related HPV types, is already FDA-approved as a follow-up for women with inconclusive or abnormal Pap results regardless of age. The age 30 cutoff was chosen because at this age women are less likely to have HPV infection, but more likely to harbor persistent infection with high-risk HPV, which can lead to cervical cancer.

For more information, visit either http://www.thehpvtest.com or http://www.digene.com .

Office-based digital U/S system with real-time 3D imaging

Aloka Co., Ltd. introduces a high-performance, digital ultrasound system for the ob/gyn office, with features that include real-time 3D volume mode for realistic fetal images. One of the key new features of the Prosound SSD-3500, which uses the most advanced acoustic technologies, is a 12-bit analog-to-digital converter that is integrated with the product's digital beam former for greater clarity and accuracy of U/S images, according to the Wallingford, Conn.-based company. Included with each system is the new integrated data management system (iDMS), which makes it easier to retrieve patient data and images. Clinician-requested features previously available only on higher-end models have been incorporated to help the ob/gyn save time.

For more information, call Peter Arneson at 203-269-5088, or visit the company's Web site at http://www.aloka.com .

 

New Products. Contemporary Ob/Gyn Oct. 1, 2003;48:98-105.