MedProMonth®
Volume 8, Number 3
March 1998
p.1

Click here to go directly to the portion of the article which references PPTI.

Incontinence.icon.gif (3470 bytes)

Strikingly positive results with behavioral methods of treating UI have been reported, with some clinicians achieving an 80% reduction in incontinence

Expanding Options for Urinary Incontinence

A growing number of options now exist for the treatment of urinary incontinence (UI), a disorder which affects an estimated 13 million people in the U.S. alone. Treatments range from behavioral therapy (e.g., biofeedback-guided pelvic floor exercises and bladder retraining), to urethral plugs and seals, pharmaceutical agents and surgery. While these techniques can provide some measure of relief for the majority of UI sufferers, fewer than half actually seek medical help for their condition, primarily due to feelings of embarrassment or a lack of knowledge about treatment options.

Although these latter two factors continue to hinder widespread diagnosis and treatment of UI, the situation is expected to improve significantly as new educational programs and dedicated continence care centers are established and a plethora of novel products become available. The largely underserved and highly fragmented nature of the current UI market adds up to a significant opportunity for both large and small competitors. Still, at the core of UI treatment remains the adult diaper and pad market, estimated at $1.5+ billion annually. A moderately incontinent consumer uses an average of about $1,200 worth of these supplies per year—an outlay that one day may, at least   partially, be diverted to new products that better meet patient satisfaction requirements and produce positive outcomes.

Rising Costs & Prevention
Societal costs associated with UI are estimated to be $28-$32 billion in the U.S. annually (Figure 27), and are expected to rise as the population ages. Interestingly, although nearly half of all UI costs are associated with medical services, only a small fraction (less than 10%) are for initial evaluation and treatment, while the majority are accrued as a result of various adverse consequences associated with long-term UI, most of which could be prevented with an effective treatment program. Efforts to control future expenditures will increasingly focus on prevention. These include patient and physician educational programs, and wider, more timely dissemination of treatment.

Figure 27: Costs Associated with Urinary Incontinence in the Elderly, U.S., 1995
fig27.gif (37547 bytes)

Notes:
Elderly population includes those aged 65+; these data assume18.8% of persons aged 65+ living in the community have incontinence, and 40% of those in institutional settings have the condition. A study presented at the American Urogynecologic Society meeting in September 1997 used higher incidence figures, and estimated the total costs (in 1995 dollars) to be $32 billion (L.L. Subak et al., University of California, San Francisco).
Source: Diane Kaschak Newman, RNC, MSN, FAAN; Ostomy/Wound Management 42(1):18-25, Jan/Feb., 1997 (presenting data compiled by Dr. Teh-Wei Hu, Professor of Health Economics, School of Public Health, University of California, Berkeley).

According to the U.S. Agency for Health Care Policy and Research (AHCPR), an effective prevention program could reduce new cases of incontinence in noninstitutionalized women alone by about 50,000 per year. The American Federation for Aging Research and the Alliance for Aging Research estimate that delaying the onset of incontinence by just five years would translate into an annual savings of $8 billion.

Widespread but Undertreated
Of the estimated 13 million Americans affected by UI, 85% of them are women. By far, the most common type is female stress incontinence, which accounts for about three out of every four cases seen by physicians (Figure 28). Stress incontinence is more common in postmenopausal women (as the lack of estrogen following menopause can weaken the pelvic support muscles), but it can also occur in younger women, usually after pregnancy and childbirth. In the combined regions of Europe, North America and Japan, a total of more than 27 million women suffer from UI (see MedPro Month VII[1]:4, 1997). Although primarily a quality-of-life issue, incontinence is associated with a wide range of serious physical and psychological problems, including depression, skin breakdown and urinary tract infections. It is also the second-leading cause of institutionalization of the elderly, afflicting at
  least 50% of the more than 1.5 million U.S. nursing home residents, and 30% of community-dwelling seniors.

Figure 28: Types of Urinary Incontinence
Fig28 Types of Urinary Inco.gif (29763 bytes)

Source: Medical Data International (from newly released MDI Report #RP-191112, "U.S. Markets for Urological Products" [table of contents available upon request])
Also see: Newly released MDI Report #RP-611335, "U.S. Women’s Health Products and Markets" (table of contents available upon request)

Despite the fact that existing treatment methods are effective at alleviating or even curing incontinence in the vast majority (up to 80%) of patients, studies show that fewer than half of incontinence sufferers seek medical assistance for their condition. Moreover, those who do seek care are often dissatisfied with their treatment or the recommendations of their physician. Primary care physicians in particular tend to be uninformed about the diagnosis and treatment of UI. They are often reluctant to query their patients about incontinence, and they tend to recommend low-tech solutions   such as pads and diapers. According to a survey conducted by the American Foundation for Urologic Disease, only 32% of primary care physicians routinely question their female patients about incontinence, compared with nearly 80% of urologists.

Continence Centers
Several recent trends in the incontinence care community may help improve the dissemination of medical treatment. One of the most notable is the growing number of dedicated continence treatment centers that have cropped up across the U.S. in the past few years, fueled by patient demands, the need to bring more procedures into the urology office (and replace the declining number of benign prostatic hyperplasia [BPH] procedures), and rising competition between urologists and urogynecologists. Although the exact number of such centers is unknown, as many as 300 or
  more incontinence clinics (private, hospital-affiliated and academic) may currently be operational, offering a variety of services ranging from surgery to behavioral therapy.

Urology physician practice management companies (PPMCs), many of which are setting up dedicated urology ambulatory surgery centers, are also poised to play a major role   in treatment expansion as well as disease management-based prevention strategies. At least five PPMCs dedicated to urology practice are already operational in the U.S. One of the newest, UROTHERAPIES (Oakbrook Terrace, IL), has plans to partner with drug and device manufacturers to facilitate adoption of the latest technology.

Deficiencies in care are also being addressed by a number of government agencies, and community and physician groups, which are supporting patient and physician educational programs. In the future, incontinence care will increasingly involve a multifaceted, individualized approach, with initial treatment focused on patient-directed, noninvasive methods, possibly followed later by least-invasive procedures.

Behavioral Techniques
In the past few years, behavioral techniques, including bladder retraining programs (e.g., scheduled voiding), and various types of pelvic muscle rehabilitation (often involving the use of biofeedback, vaginal weight training and electrical stimulation therapy), have become some of the most widely used first-line therapies for the treatment of UI. This segment will continue to be driven by patient preferences, positive outcomes data, strong endorsements in the most recent AHCPR treatment guidelines and the proliferation of outpatient treatment centers.

Behavioral methods are attractive to both patients and physicians because they are noninvasive, have no or minimal side effects and provide patients with control over their care. According to a recent survey conducted by the Bladder Health Council   for the American Foundation for Urologic Disease, of women age 45 and older being treated for incontinence, nearly 40% received behavioral therapy, while the remainder were about evenly split between surgical treatment, medical therapy and no treatment (i.e., either the doctor did nothing or recommended absorbent pads). Strikingly positive results with behavioral methods have been reported, with some clinicians achieving an 80% reduction in UI using a combination of techniques.

Biofeedback and pelvic floor stimulation (PFS) devices for the treatment of UI are available from at least 13 U.S. manufacturers. Among those displaying products at the American Urogynecologic Society meeting, held last September in Tucson, AZ, were AMERICAN IMEX (Irvine, CA), INCARE MEDICAL PRODUCTS (Libertyville, IL), SRS MEDICAL SYSTEMS (Redmond, WA), VERIMED INTERNATIONAL (Coral Springs, FL) and EMPI (Minneapolis, MN). The latter, a leading provider of electrical stimulation systems for both incontinence and pain management, showcased its new InnoSense PFS system, which combines surface electromyography (sEMG) biofeedback and electrical stimulation in a low-cost, battery-powered device. In addition to the recently launched InnoSense product, EMPI has been granted FDA approval to market Minnova, a new device developed to simplify and lower the cost of pelvic floor stimulation in treating both stress and urge UI. Minnova addresses the need for low-cost continuation therapy for patients in the home setting.

Additional competitors in PFS and biofeedback include BIOSONICS (Fort Washington, PA), which will begin marketing its Cystotron PFS device in the U.S. this year, and INFLUENCE (San Francisco, CA), which is developing In-Bio, a wireless system that combines biofeedback and electrical stimulation.

Growth & Reimbursement
EMPI has been working for some time to gain Medicare reimbursement for pelvic floor electrical stimulation, which is commonly performed by the patient at home. Although clinic-based biofeedback and pelvic exercise training visits are
  usually well-reimbursed, lack of Medicare reimbursement for PFS has hindered acceptance and use of electrical stimulation technology. The Health Care Financing Administration recently commissioned Blue Cross & Blue Shield to determine if national Medicare coverage for PFS should be granted. Reimbursement is generally a neutral factor for the incontinence therapy device market which, excluding sales of diapers/pads, reached an estimated $250 million in the U.S. last year. Of this amount, about 73% was generated by male external catheter systems. Driven by the aging population, the total market is predicted to grow at a rate of about 30% per year, reaching nearly $850 million by the year 2001 (Figure 29).

Figure 29: Incontinence Management Devices, U.S. Market Forecast, 1997E & 2001E
Fig29 Incontinence Mgmt.gif (26220 bytes)

*Includes male external and intermittent catheters.
Source: Medical Data International (from newly released MDI Report #RP-191112, "U.S. Markets for Urological Products" [table of contents available upon request])
Also see: Newly released MDI Report #RP-611335, "U.S. Women’s Health Products and Markets" (table of contents available upon request)

Implantable Stimulators
The next generation of PFS devices may well be implantable. One company, UROSURGE (Coralville, IA) is developing an urge UI nerve stimulation device that administers electrical pulses to a bundle of nerves near the ankle thought to control bladder contractions. The company hopes to eventually develop an electronic receiver that can be permanently implanted into the ankle. UROSURGE currently markets the $160 AcuTrainer bladder retraining device. The company is also developing the Self-Detachable Balloon System, a bulking system for the treatment of intrinsic sphincteric deficiency (ISD), discussed below.

The first fully implantable electrical stimulator for severe, refractory urge incontinence is MEDTRONIC’s (Minneapolis, MN) Interstim. The device, which received FDA marketing approval last September, is about the size of a pacemaker and is implanted near the spinal cord where it delivers electrical pulses to the sacral nerves to control bladder contractions. Cost of the unit is about $10,000, plus an additional $15,000 for the implant surgery. In clinical testing, the device "cured" about 47% of patients, and cut leakage in half in another 28%. However, 35% of patients reported long-term pain from the device and required additional surgery to reposition the implant.

Disappointing Performances
While new UI devices often appear very promising at the outset, poor patient or
  physician acceptance or less than optimal long-term efficacy often add up to a disappointing sales performance. Such is the experience of two of the most widely touted and seemingly promising therapies introduced in the past few years—BARD’s (Billerica, MA) Contigen collagen injection and UROMED’s (Needham, MA) Reliance female urethral insert. Reliance, which was launched in the U.S. late in 1996, has had very disappointing sales (less than $1 million estimated for 1997), apparently due in large part to the reluctance of women to use the product, which can cause discomfort. In studies presented at the 1997 American Urological Association meeting, Reliance was discontinued in 24 of 79 patients due to either discomfort, difficulty with use, or persistent leakage. Of 39 patients who used the device for two years, over 43% had at least one urinary tract infection.

Contigen has been up against disappointing physician acceptance. Sales have been relatively flat ($30-$40 million per year) since the product was introduced in 1993. Manufactured by COLLAGEN (Palo Alto, CA) and marketed by BARD, Contigen is an injectable, collagen-based urinary sphincter bulking agent for the treatment of stress incontinence due to intrinsic sphincteric deficiency, which affects about 15% of stress UI sufferers. However, it does not work well for male incontinence (only 40% of men attain dryness when treated with the product). For women, there is uncertainty about the dosage required per treatment, and many need repeated treatments, at a cost of about $1,800 each, to achieve complete dryness.  

New Inserts, Patches & Caps
A summary of treatment options for UI is presented in Figure 30. Among the many new product introductions are two devices from UROMED—the Impress urethral patch for mild to moderate female stress UI and the Introl bladder neck prosthesis, which was acquired from JOHNSON & JOHNSON (New Brunswick, NJ). Impress is expected to achieve better patient acceptance than Reliance since it is not inserted into the urethra, but is simply placed over the urethral opening to create a seal. Introl is fitted and dispensed by a
  clinician, and can be worn continuously for up   to 24 hours before it is removed and cleaned by the patient and reinserted. It simulates the effect of bladder neck suspension surgery, elevating the bladder to its normal position for relief of stress UI due to hypermobility.

Poor patient or physician acceptance of UI treatment devices or less than optimal long-term efficacy have often resulted in disappointing sales performance

Periurethral bulking agents hold much promise as lower-cost, less-invasive alternatives to surgery for patients with intrinsic sphincter deficiency

Figure 30: Current & Future Treatment Options for Urinary Incontinence
Fig30 Current & Future Trea.gif (242787 bytes)

*In development in the U.S. **Also see Figure 31,
Note: UI = urinary incontinence; ISD = intrinsic sphincter deficiency
Sources: UBS Securities; Medical Data International (Based on information from two newly released MDI Reports: #RP-191112, "U.S. Markets for Urological Products" and #RP-611335, "U.S. Women’s Health Products and Markets" [table of contents for both reports available upon request])

Drugs can benefit some patients with UI but they often have troublesome side effects

Last month, the company announced its intention to decrease its investment in the consumer-oriented continence care business by securing marketing partners to sell and distribute Impress. The firm, which will concentrate its efforts on hospital-based products, has also been diversifying its product line in order to reduce its dependence on the incontinence market. Late last year, UROMED received FDA marketing clearance for CaverMap, a unique nerve-locating device that has proven valuable in preventing   impotence during prostate removal surgery; its BreastCheck and BreastExam battery-powered tactile sensor devices for detecting breast lumps are scheduled to begin clinical testing this year.

ROCHESTER MEDICAL (Stewartville, MN) began clinical trials early last year of its FemSoft insert, a lubricated, fluid-filled device that conforms to the natural contours of the urethra, providing more comfort and less irritation than more rigid devices like Reliance, according to the company. Another new product, the FemAssist urethral cap developed by INSIGHT MEDICAL   (Bolton, MA), has exhibited some promising early clinical results. The soft, silicone device is fitted over the external urethral meatus and is held in place by mild suction and an adhesive sealant ointment. It is removed for urination, cleaned with soap and water, and reapplied, with a single device worn for up to one week. A recent study found that the device was well tolerated and effective in reducing female stress, urge or mixed incontinence. According to the company, the FemAssist will cost about $40 for a one-month supply (i.e., four devices plus ointment).

Bulking Products Evolve
Despite disappointment with Collagen, periurethral bulking agents hold much promise as lower-cost, less-invasive alternatives to surgery for patients with ISD. Several companies are pursuing this solution. REPROGENESIS (Charlotte, NC) is working on a unique urethral implant comprised of autologous chrondrocytes harvested from the patient’s ear. The cells are cultured and suspended in a hydrogel matrix, then delivered via catheter to the area around the sphincter, where they eventually produce cartilage to replace the hydrogel and bulk the sphincter. The company has a market development alliance with AMERICAN MEDICAL SYSTEMS (AMS)/PFIZER (New York, NY).

MENTOR (Santa Barbara, CA) is seeking FDA approval for its silicon-based product, Urithryn. In addition, CONVATEC (Princeton, NJ; a division of BRISTOL-MYERS SQUIBB) is conducting clinical trials of a bulking agent incorporating calcium hydroxylapatite granules; while BIOMATRIX (Ridgefield, NJ) recently received FDA approval to begin clinical trials of a hyaluronan-based viscoelastic gel, Hylagal Uro. Another firm, PROTEIN POLYMER TECHNOLOGIES (San Diego, CA), has begun preclinical studies of biocompatible polymer bulking agents (the company’s technology platform is also applicable to surgical adhesives and sealants—see article 1). A new entry in the periurethral bulking agent market is GENYX MEDICAL (Laguna Niguel, CA), a recent spinoff of MICRO THERAPEUTICS (San Clemente, CA; also see article 5) which has licensed the latter’s EMBOLYX bulking agent for urologic/gynecologic uses. The product, which has been renamed URYX, is an injectable biocompatible polymer of ethylene vinyl alcohol and contrast material that forms a solid mass once inside the body. In addition to urethral bulking, GENYX also hopes to use the material for reversible male (and possibly female) sterilization procedures.

A number of products are under development in Europe, as well. UROPLASTY (The Netherlands) has developed a novel hydrogel sphincter implant in Europe (see MedPro Month VII[1]:5, 1997); QVESTOR, a Swedish company, is in clinicals with Deflux, an implant composed of sodium hyaluronate and dextranomer microspheres; and U.K.-based UROCOL is pursuing a ceramic bead bulking product.

A different approach has been taken by UROSURGE. The company’s Self-Detachable Balloon System, in Phase II clinical testing, is intended to provide a bulking system that,   unlike collagen and similar products, poses no risk of systemic absorption and possible side effects. It is administered during a 15-minute cystoscopic procedure in which a catheter is used to position and deliver three microballoons (one at a time) into the submucosal layer at the site of the sphincter muscle. The balloons are inflated with hydrogel, detached from the catheter, and subsequently seal themselves. In Phase I trials, 63% of women treated with the system achieved dryness, while 89% reported subjective improvement.

Drug Solution?
While drugs can benefit some patients with UI, they rarely cure the disorder and most have troublesome side effects. Thus, drugs are usually recommended only in conjunction with other treatments, such as behavioral therapy. Nevertheless, new drugs in the pipeline may improve the dosing schedule and reduce side effects (Figure 31). Two of the most promising include PHARMACIA & UPJOHN’s (U.K.) Detrusitol, which is awaiting FDA approval, and ALZA’s (Palo Alto, CA) OROS-oxybutynin, in late Phase III development. Both are intended to address convenience and side effects issues associated with branded and generic oxybutynin,
  currently the most   widely used drug for urge incontinence. While oxybutynin must be administered three times per day, Detrusitol requires only twice-daily dosing, and ALZA’s OROS-oxybutynin is taken only once per day.

Figure 31: Urinary Dysfunction Drugs in Clinical Trials
Fig31 Urinary Dysfunction.gif (77303 bytes)

Sources: R&D Directions; Medical Data International

New Catheter Devices
A number of other interesting new UI products are also in development, many of them catheter-based devices. ROCHESTER, which currently markets a line of male external catheters and a silicone internal catheter, is developing an antibacterial Foley catheter incorporating the antibacterial agent nitrofurazone. The company will have some competition in the antimicrobial catheter arena from DIAGNOSTIC ULTRASOUND (Redmond, WA), manufacturer of the BladderScan and Bladder Manager ultrasound devices for the management of urinary retention in spinal cord injury patients. The company recently aligned with IMPLEMED (Watertown, MA) to develop a variety of urology catheters and incontinence products containing OLIGON antimicrobial technology.

ROCHESTER is also developing a valved catheter for female patients. Valved catheters are the newest innovation for patients with chronic, refractive stress or overflow UI, providing a more convenient and potentially safer alternative to intermittent catheterization. Inserted into the urethra by a physician and left in place for up to a month at a time, the devices block urine flow until the patient opens the valve for urination, usually via a remote device.

In addition to ROCHESTER, valved catheters are under development by INFLUENCE, IMAGYN MEDICAL TECHNOLOGIES (Newport Beach, CA; merged with UROHEALTH SYSTEMS in 1997) and UROQUEST (Salt Lake City, UT). The latter is conducting clinical trials of its On-Command magnetically activated valved catheters for both men and women (the firm has a development agreement with B. BRAUN [Germany]). ROCHESTER plans to begin clinical trials this year of its FemSoft female valved catheter, designed to be   replaced every day, while both the 29-day INFLUENCE In-Flow valved-pump catheter for overflow incontinence and the IMAGYN RelaX valved devices are undergoing clinical testing (INFLUENCE expects to file a PMA this year for its device, which is marketed in Europe).

Another device worth mentioning is HK MEDICAL’s (San Antonio, TX) Autocath 100 intraurethral sphincter prosthesis for female stress UI due to ISD. This product received European market approval in October and is undergoing clinical testing in the U.S. The Autocath 100 is inserted in a nonsurgical, 10- minute procedure in which it is suspended on the bladder floor from a X-shaped spring. It is designed to hold the sphincter muscle closed until the patient uses abdominal pressure to open the device for urination.

Advances in Urodynamics
The potential to add incremental income to practices, coupled with the availability of less-expensive, portable, office-based systems, is expected to result in a doubling of the number of urodynamic studies performed in the U.S., to over 2 million, by the year 2001 (Figure 32). Urodynamic studies evaluate the storage and transport of urine within the urinary tract, as well as the causes of abnormal voiding. They are useful in diagnosing UI, as well as a number of other disorders such as neurogenic bladder disease, spastic sphincters and urinary path obstruction.

Figure 32: Urodynamic Measurements, U.S. Procedural Forecast, 1996-2001
Fig32 Urodynamic Measure.gif (19511 bytes)

Notes:
Figures are rounded. Active installations include both urology and urogynecology.
Source: Medical Data International (from newly released MDI Report #RP-191112, "U.S. Markets for Urological Products" [table of contents available upon request])

Recent developments in urodynamic products include new office-based systems with complex capabilities, the introduction of diagnostic database management systems as well as highly sophisticated video urodynamic equipment and devices that can also perform gastroenterology studies (e.g., manometry or rectal pressure studies). Manufacturers include BARD UROLOGICAL (Covington, GA), LABORIE MEDICAL TECHNOLOGIES (South Burlington, VT), LIFE-TECH (Houston, TX), and several others.

An estimated 5,500-6,000 urodynamic installations currently exist in the U.S., the majority   operated by urologists. In 1996, these installations performed over 1 million urodynamic studies, 85% of which took place at office-based or freestanding sites. Although urodynamic studies are still largely   underutilized in the U.S., the growing incontinence caseload is leading to greater utilization and an increasing number of specialists offering urodynamic analysis. One of the drawbacks to wider use of these systems is cost and reimbursement. The average patient undergoes three urodynamic studies during the course of an evaluation, at a cost which typically ranges from $100 to $300 or more each (only partially paid for by insurance).

Surgical Techniques Evolve
With the development and greater acceptance of nonsurgical treatments for UI in the past few years, incontinence surgery has been on the decline. According to INFLUENCE, about 120,000 of these surgeries were performed last year, compared with 140,000 in 1995. Although most UI sufferers prefer a nonsurgical solution, studies show that in properly selected patients, surgery offers some of the highest "cure" rates of any available treatment, with 62-92% of patients achieving dryness following surgery, compared to less than 50% of patients on drug therapy.

In 1997, the American Urological Association released treatment guidelines which strongly recommend the use of surgery as a first line of treatment for female stress UI. According to the guidelines, there is strong evidence to suggest that surgery provides an effective long-term cure for most patients, with retropubic suspensions and sling procedures offering better results than transvaginal suspensions (although the former also have higher complication rates). The evolution of laparoscopically assisted and incisionless techniques may eventually improve transvaginal success rates.  

Bone Anchors Gain
Bone anchoring systems for the stabilization of
  sutures and sling materials during incontinence surgery are experiencing rapid   penetration of the urology market. They offer several advantages over other methods, many of which are associated with the ability to deliver the anchors percutaneously, and include reduced operating time, shorter hospital stay, and lower costs. In addition, anchoring the soft tissue of the bladder to a firm structure such as the pelvic bone also appears to offer greater long-term stability. The growing adoption of bone anchoring systems, by both urologists and urogynecologists, is expected to not only result in significant growth in this market segment, but to also boost the total number of UI surgeries performed annually. By the year 2001, over half of all stress incontinence surgeries in the U.S. (more than 150,000) are expected to utilize bone anchor systems, resulting in product sales nearing $130 million (Figure 33).

Figure 33: Bone Anchor Systems, U.S. Market Forecast, 1997E & 2001E
Fig33 Bone Anchor Systems.gif (17916 bytes)

Note:
Sales compound annual growth rate (1996-2001) = 90.5%
Source: Medical Data International (from newly released MDI Report #RP-191112, "U.S. Markets for Urological Products" [table of contents available upon request])
Also see: Newly released MDI Report #RP-611335, "U.S. Women’s Health Products and Markets" (table of contents available upon request)

The broadening popularity of bone anchors for UI surgery has prompted many manufacturers to introduce products (some of which were originally designed for orthopedic uses) to this market, including MICROVASIVE/ BOSTON SCIENTIFIC (Natick, MA), MENTOR, AMS/PFIZER, ETHICON (Somerville, NJ), INFLUENCE, INNOVASIVE DEVICES (Marlborough, MA)/UROMED and WRIGHT MEDICAL (Arlington, TN). MICROVASIVE/BOSTON SCIENTIFIC is the market leader—its Vesica procedure (and products) is marketed as a way for physicians to achieve more reproducible results than can be obtained with other methods and products.  

Other manufacturers, including INFLUENCE and MENTOR, are planning to introduce additional components to their bone anchor lines, such as bone locators and sling material, but unlike the Vesica kit, these manufacturers will market each component separately, a strategy intended to give physicians greater flexibility in their choice of products. INFLUENCE is the only company to offer products for incisionless, transvaginal bladder neck suspension or sling procedures, which take place under local anesthesia and can be performed in as little as 20 minutes. Due to the shorter procedural time, these products have caught the attention not only of urologists, who have readily embraced bone anchoring systems, but also of urogynecologists (and gynecologists performing incontinence surgery) who are generally more experienced in laparoscopic suturing and have thus far tended to avoid the use of expensive bone anchors.

New Market Entrants
Two new entrants to the UI bone anchor/ fixation market are INNOVASIVE and LI MEDICAL TECHNOLOGIES (Stamford, CT). The former received FDA approval for its polymer-based anchoring products for UI last October. Previously focused solely on the arthroscopy market, INNOVASIVE signed an agreement last November that allows UROMED to market their anchoring devices to the urogynecology market. LI MEDICAL is pursuing a proprietary, minimally invasive fixation technology which utilizes fundamental penetrating beam techniques. This technology allows soft tissue-to-bone fixation, providing, in the case of incontinence surgery, a minimally invasive type of bladder neck suspension without the need for bone anchors. The company is targeting three markets for its technology: spinal fusion, incontinence (stress UI) and sports medicine (joint stability).
 

The broadening popularity of bone anchors for UI surgery has prompted many manufacturers to introduce products to this market

Copyright © 1998 Medical Data International

This article was published in the March 1998 issue of MedPro Month, Medical Data International's monthly
newsletter that provides critical insight and strategic business information to healthcare executives around the world.
For more information on MedPro Month visit

www.medicaldata.com

mitanim.gif (17436 bytes)



Site Directory
webmaster@ppti.com
Legal Notices

©1998 Protein Polymer Technologies, Inc. All rights reserved.
Redistribution, retransmission, republication or commercial exploitation of the contents of this site
are expressly prohibited without the written consent of Protein Polymer Technologies, Inc.