Innovations In A Healthy Sector
Medical textiles are found in numerous health-promoting and sometimes life-saving end-products.
Jennifer Dennard, Associate Editor
When faced with the fact that 5 to 20 percent of the US population contracts the flu each year, and more than 200,000 people are hospitalized annually due to complications from it, one wonders how to head off this always inconvenient, sometimes deadly illness.
Following simple CDC guidelines, such as taking antiviral medications, avoiding close contact with sick people, and covering the mouth and nose with a tissue when sneezing or coughing can go a long way towards guarding against the flu.
"The truth is that the flu shot does not offer 100-percent protection against influenza, and there will not be enough vaccine to cover those in high-risk categories such as those with compromised immune systems," said Winkler G. Weinberg, M.D., chief of infectious diseases, Southeast Permanente Medical Group, Atlanta; and author of "No Germs Allowed, How to Avoid Infectious Disease at Home and on the Road."
"As demonstrated by a new study, the more serious problem is that too many people do not practice good respiratory hygiene, which is the key to helping stop the spread of cold and flu viruses," Weinberg added.
Kimberly-Clark Corp., Neenah, Wis., has taken this last piece of advice to heart and introduced Kleenex® Anti-Viral tissues. The facial tissue's patented three-layer design features a moisture-activated middle layer treated with an antiviral formula made from sodium lauryl sulfate and citric acid. This layer starts working immediately upon contact with moisture from a sneeze or cough. Within 15 minutes, 99.9 percent of cold and flu viruses are destroyed.
This tissue is just one of the many medical textile products consumers use everyday. Such products are all around us. Whether it be a temperature therapy patch or medicated pad used to relieve pain from arthritis or a sports injury; wound dressings that impart medication for faster healing; surgical mesh for hernia repair; vascular grafts and patches that restore blood circulation and enable longer life; polyester implants that alleviate snoring and sleep apnea; or apparel that enables the body to increase its own oxygen levels, build strength and quicken muscle recovery; medical textiles play a prominent, yet often overlooked role in the health of our society.
The three-layer Kleenex® Anti-Viral tissue from Kimberly-Clark Corp. features a moisture-activated middle layer with a special antiviral formula to trap and kill viruses.
Strolling The Aisles For Pain Relief
Perhaps the most recognized medical textile products are patches and pads that use medication and/or temperature therapy to relieve pain. These products offer quick relief to common pains such as arthritis flare-ups and sports-induced muscle aches.
The Ultra Strength BENGAY® Pain Relieving Patch from Pfizer Inc., New York City, delivers heat to an affected area, relieving tension and soreness. The Mentholatum Co. Inc., Orchard Park, N.Y., offers WellPatch™ Heat Warming Pads, breathable cloth pads that use activated carbon, iron powder, sodium chloride and water to generate pain-relieving heat for up to eight hours. Mentholatum also offers pads that generate cooler temperatures to treat migraine headaches, sprains, arthritis and backaches.
Chattem Inc., Chattanooga, Tenn., also offers a variety of pads and patches, including Aspercreme® Odor-Free Therapy medicated back and body patches, and the popular Icy Hot® line of products. This line includes the Icy Hot Back Patch; and the recently introduced knitted Icy Hot Sleeve™, which, when placed around painful joints, concentrates pain-relieving medicine. The sleeve uses Sorbtek® technology from Unifi Inc., Greensboro, N.C.,to disperse and dispense the Icy Hot medication.
Playtex™ Heat Therapy™ patches from Playtex, Westport, Conn., offer up to 12 hours of similar temperature-induced relief for menstrual cramps.
Cramer Products Inc., Gardner, Kan., a supplier to the sports medicine industry and founder of the National Athletic Trainer's Association, offers Quickwrap™, a cotton/nylon-blend elastic fabric wrap that features a removable cold compression Flex-i-Cold™ pack for pain relief. Cramer also offers Nova Derm™ - a sterile wound dressing composed of a glycerin gel pad with cloth backing for pain relief associated with cuts, burns and scrapes.
Going To The Doctor
When the time comes to visit the general physician or undergo a surgical procedure, medical textiles often make the difference, speeding up recovery time and preventing recurring trips to the doctor's office.
Mothers and newborns often find their time in the hospital made less stressful by products from Cardinal Health Inc., Dublin, Ohio. Cardinal provides women with a variety of post-delivery warm and cold packs that reduce pain and swelling. The company's product line also includes neonatal thermal products such as the Porta-Warm™ nonwoven, latex-free, vibration-absorbing wrapped mattress for the transportation of babies between or within medical facilities.
A trip to the dermatologist may result in the recommendation that a child suffering from atopic eczema - a chronic itchy rash that results in dry, scaly skin - use a Coverflex® wet wrap treatment bandage from Paul Hartmann AG, Germany, to reduce skin inflammation and produce a cooling effect that reduces itching.
Hartmann also offers the Hydrocoll high-absorbency wound dressing, which features a germ and waterproof top layer and rapid absorption that prolongs its effectiveness.
Wound care products are part of an expanding market - the advanced wound care market is growing at a rate of 15 percent per year, according to Sweden-based Mölnlycke Health Care. Mölnlycke targets home and acute wound care professionals with its Tendra® line of conventional and advanced wound dressings designed to stimulate and promote the healing process.
The Freudenberg Nonwovens Group and BSN Medical GmbH & Co. KG, both based in Germany, specialize in wound care products as well.
Sutures are the oldest and most common material used to close wounds, join tissue and tie off bleeding vessels. Gone, fortunately, are the days when cat gut, horse hair, strips of hide or bark fibers were used. Today, sutures are mono- or multifilament threads that make up a large part of the wound care segment.
Quill Medical Inc., Research Triangle Park, N.C., and Surgical Specialties Corp., Reading, Pa., recently obtained clearance from the Food and Drug Administration (FDA) for Contour Thread™, a new suture technology developed as a result of the companies' recent alliance. Contour Thread is targeted to dermatologists and cosmetic surgeons as a minimally invasive product for lifting skin. According to the companies, it promotes faster wound closure, improved healing and reduced scarring.
Contour Thread is offered in two versions - a barbed, nonabsorbable polypropylene suture for use in facelift surgery; and a barbed, absorbable polydioxanone suture for dermal closure. Both products are made of suture-grade monofilament fiber. The technology behind the thread is based on Quill Medical's self-anchoring suture design, which enables tissue to connect without lacing the wound or tying knots.
"For wound closure, our product can be placed faster since no knots are needed," said Jeffrey C. Leung, Ph.D., vice president, technology and development, Quill Medical. "Studies have suggested better wound healing and potential cosmetic appearance benefits."
Wound care products have found medical applications outside of the hospital as well. Shieldex Trading USA, Palmyra, N.Y., offers its recently released STATEX® silver metallized fabrics and yarns for wound dressings for use by veterinarians in the United States to treat horses and other animals. Silver is known for its ability to inhibit bacterial growth, decreasing infection risk and thus promoting wound healing. Veterinary end-products include contact dressings to manage partial thickness burns, lacerations, abrasions and incisions.
According to Shieldex, the new fabric has shown excellent results in tests by horse trainers for healing proud flesh, hoof fungus and saddle and girth sores.
Statex fabrics and yarns are currently in use as wound dressings in Asia and Europe; in the United States, FDA approval for human use of the product is pending.
Other medical textiles used in the operating room include vascular grafts and implants - artificial arteries or veins that replace parts of the body's cardiovascular system that have been blocked or weakened by disease.
Intervascular Inc., Montvale, N.J., offers InterGard UltraThin, the thinnest knitted polyester collagen-coated graft in the market today, according to the company. Collagen helps to make the graft more comfortable and more benign to the body, hopefully preventing the need to regraft later on. Collagen also is reputed to aid in the decrease of plaque formation.
Intervascular's product line also includes knitted grafts made of highly filamentous texturized yarn incorporated into a reverse locknit construction, woven grafts made of highly filamentous yarns with low twist, and vascular patches that promote reduced healing time and eliminate suture hole bleeding.
Bally Ribbon Mills, Bally, Pa., a producer of woven and braided materials, sells those materials to cut-and-sew manufacturers, which develop them into a variety of end-products. At the Industrial Fabrics Association International Expo held recently in Pittsburgh, the company displayed its extensive range of vascular products including woven tubular vascular stents, tapered weaves and arteries, and bifurcate grafts, among other products that are used to repair damaged blood vessels.
The medical products division of Elkton, Md.-based W. L. Gore & Associates Inc. - known for its popular GORE-TEX® fabric - has produced for almost 30 years an extensive line of man-made patches and blood vessels used in soft-tissue regeneration, and surgical sutures for a variety of procedures.
This year, the company has introduced collagen-coated polyester vascular patches and prostheses to its extensive product line of expanded polytetrafluoroethylene (ePTFE) vascular and endovascular devices.
The low-permeability Gore EXCLUDER® bifurcated endoprosthesis, introduced to Gore's endo-abdominal aortic aneurysms (AAA) excluder device product line in September, offers exceptionally reduced permeability during treatment of AAA. The device is constructed out of a long-lasting ePTFE graft, ePTFE reinforcing film, a low-permeability film layer, an electropolished nitinol stent, and bonding film used in stent-to-graft attachments.
"Our long-term data indicate the device is performing extremely well," said Elizabeth Hoff, aortic marketing leader at Gore. "More than 17,000 patients have been treated with the Gore Excluder device worldwide since the first implant in 1997, with very low complications such as device migration. In addition, we've had no issues of limb disconnections, and, most importantly, our rupture rate and reintervention rate remains extremely low, which demonstrates the device is providing excellent patient outcomes."
Proceeding With Hernia Repair
According to the National Center for Health Statistics, Hyattsville, Md., around 5 million people in the United States have hernias - a condition in which part of a tissue or organ (usually a piece of intestine) protrudes through an abnormal opening in the body.
Hernias often are repaired with polypropylene mesh fabrics because of polypropylene's resistance to infection and antiallergenic properties. Hernia repair products include the Gore-Tex ePTFE soft tissue patch; and Proceed® surgical mesh from Ethicon Inc., an operating company of Johnson & Johnson, New Brunswick, N.J.Proceed is a multilayered tissue made up of Prolene® soft polypropylene monofilament mesh that separates tissue in open and laparoscopic incisional hernia repair. Its thin, bioresorbable fabric layer separates the mesh component from underlying viscera, enabling flexible scar tissue to develop and preventing the harboring of bacteria.
The Pillar™ Palatal Implant System consists of three woven inserts placed in the soft palate to reduce obstruction of the airway and vibration that causes snoring.
Implant Your Snoring
And Sleep Apnea Away
Suffering sleepless nights because a loved one's sonorous snoring is keeping you up makes for grumpy days at the office. Restore Medical Inc., St. Paul, Minn., in cooperation with the Center for Corrective Surgery, Bala Cynwyd, Pa., has developed a surgically implantable device that helps alleviate this nocturnal nuisance.
The Pillar™ Palatal Implant System is a set of three 18-millimeter-long nonabsorbable pieces of polyester yarn that, when implanted into the soft palate of the mouth, reinforce and stiffen tissues that often flutter and obstruct upper airways, causing the bothersome snoring sound.
Pillar inserts are manufactured using braiding machines from Spartanburg-based Steeger USA Inc.
"What I like about this system is that it does not involve heating or removing tissue, which minimizes swelling and post-procedure pain," said Mansoor Madani, Ph.D., director of the center. "It is retrievable as well. Most patients can resume normal activities and diet shortly after the procedure," he added.
The procedure was approved earlier this year by the FDA for treatment of sleep apnea - the recurring cessation of breathing dozens, sometimes hundreds, of times a night. According to the company, a recent clinical study showed sleep apnea was reduced in nearly 80 percent of sufferers who underwent the Pillar procedure.
Stedfast Inc. manufactures coated, laminated and calendered barrier fabrics that protect medical staff and patients from bacteria and infection.
Protecting Doctor And Patient
Companies such as Ahlstrom Corp., Finland; DuPont, Wilmington, Del.; BBA Fiberweb™, Nashville, Tenn.; and Consoltex Inc., Montreal; specialize in the production and coating or laminating of barrier fabrics that, once made into garments, protect medical personnel and patients from contamination by infectious fluids. These products can include emergency and operating room drapes; bed linens; and surgeons' and nurses' caps, masks, coats and footwear.
DuPont continues to make advances in the barrier fabrics segment. The company recently opened a $130 million facility in Old Hickory, Tenn., for the production of nonwoven fabrics using DuPont's proprietary Advanced Composite Technology (ACT).
ACT's initial product offering is DuPont™ Suprel™, an extremely protective and comfortable disposable fabric made from continuous filament fibers and used in patient drapes and operating gowns. The fabric was developed in cooperation with operating room nurses who participated in comfort studies conducted at Raleigh, N.C.-based North Carolina State University.
Suprel is the only medical fabric on the market that combines polyester and polyethylene for strength and softness, according to DuPont. Other features include reduced surface friction and the ability to transfer heat quickly away from the body.
"[This] composite fabric technology will allow us to create an array of fabrics in direct response to the evolving needs of the medical industry," said David Flitman, director, DuPont Nonwovens Global Business. "Suprel is the first in a line of innovative products from DuPont that will raise the bar for standards of protection and comfort in medical fabrics."
Glen Raven Technical Fabrics LLC, Glen Raven, N.C., is a vertical supplier of reusable GlenGuard® Rx barrier fabrics to such cut-and-sew manufacturers as Encompass, McDonough, Ga.; Medline Industries Inc., Mundelein, Ill.; and Superior Uniform, Seminole, Fla. These companies sell the finished barrier garments directly to hospitals.
Products made with GlenGuard Rx barrier fabrics are used in such applications as surgical, patient and isolation gowns; surgical drapes; instrument wraps and surgical table covers.
Glen Raven fabrics are approved by the Association for the Advancement of Medical Instrumentation, Arlington, Va. Glen Raven finishes its fabrics at its sister division, Park Avenue.
North Charleston, S.C.-based Polymer Group Inc. (PGI) introduced a line of barrier fabrics earlier this year. According to PGI, MediSoft™ fabrics are exceptionally soft, which is unusual for high-fluid barrier fabrics produced using spunmelt processes. Significant proprietary advances in PGI's spunmelt manufacturing process enabled it to produce the softer fabric.
"MediSoft fabrics give PGI the ability to offer the comfort and convenience of spunlace fabrics with the higher protection and cost advantages of spunmelt technology," said James L. Schaeffer, CEO.
The fabrics, which are produced at a PGI facility in China, exhibit a 50-percent improvement in drapability compared to standard spunmelt fabrics for medical applications; and a 40-percent improvement in softness, according to the company.
Another new advancement in barrier fabrics is HaloShield® coating technology from Vanson HaloSource, Redmond, Wash. HaloShield is a patented, durable coating technology that binds antimicrobial chlorine molecules from Environmental Protection Agency (EPA)-registered chlorine-based sanitizers such as Clorox® - proven hygienic agents that do not encourage resistant microbes - to almost any textile or surface to eliminate infection-causing pathogens within 30 seconds to an hour, depending on application.
Vanson HaloSource currently licenses HaloShield to Medline - the largest privately held national manufacturer and distributor of medical supplies - which distributes HaloShield-treated bed linens, hospital scrubs, gowns, sheets, pillowcases and reusable underpads in North and South America.
According to Medline, hospital-acquired (noscomial) infections kill 60,000 to 80,000 people a year at an average cost of $6 million per hospital - adding more than $5 billion to US healthcare costs overall.
"HaloShield acts like Velcro® for chlorine molecules," said Sean Manne, director, HaloShield Coatings, Vanson HaloSource. "It locks chlorine in place until it comes into contact with and kills the microbe, then releases it. Lab tests show that when bacteria or viruses come into contact with chlorine bleach anchored to a sheet treated with HaloShield, 99.9 percent of the microbes are killed within minutes, compared to the 12- to 24-hour kill time seen with many competing technologies."
According to Medline, the antimicrobial properties of the chlorine are renewed when the sheet is laundered in an EPA-registered chlorine-based sanitizer; between launderings, the coating prolongs and enhances the antimicrobial properties of the sanitizer. It is effective with such textiles and nonwovens as cotton, rayon and blends; polyester and polypropylene; and nylon, Lycra®, Spandex® and Dacron®.
Stedfast Inc. is a Quebec-based manufacturer of coated, laminated and calendered barrier fabrics. Its line of STEDAIR® fabrics is targeted to first responders and other emergency medical services. The Stedair fabric line includes: EMS highly-engineered breathable moisture-barrier fabrics that protect the wearer from bodily fluids and inhibit bacterial and viral penetration; and surgical drape and gown fabrics that have a laminated moisture vapor-permeable barrier built into the garment, enabling it to be washed, sterilized and reused.
Shawmut Corp., West Bridgewater, Mass., also laminates barrier fabrics to provide a wide array of materials to the medical industry. Shawmut laminates thin barrier films using its room-temperature curing adhesive system, which does not subject the films to excessive heat and pressure. The company's products include durable, breathable barriers; disposable barriers; orthopedic barrier fabrics; and other medical devices such as blood pressure cuffs, lymphadema prevention devices and low air-loss mattresses, and lumbar supports used in seating applications.
MediSoft™ barrier fabrics from Polymer Group Inc. offer exceptional softness.
Promoting A Healthy Future
With so many uncertainties in today's economy regarding health insurance and benefits, it is reassuring to know that the medical textiles field will continue to offer new health-improving, and even life- prolonging and -saving products.If it weren't for such products as vascular grafts, stents, barrier fabrics and pain-relieving patches, among many others, many patients and doctors would not lead the lives they live so actively today. Medical textiles will continue to help ensure a long and healthy future.
Wrapping The World In Holofiber®
It is no surprise that to gain a strong foothold in the medical textiles sector and remain competitive, multiple product applications must be created that appeal to doctors, patients and general consumers.
Holofiber®, touted as the world's first body-responsive fiber, is one such product. Introduced last year after 10 years of development by Hologenix LLC, Charlotte - a joint venture company formed by Wellman Inc., Shrewsbury, N.J.; and Holofiber LLC, Los Angeles - Holofiber is a proprietary textile that has found applications in both the compressive garment and sportswear markets.
Holofiber's polyester base features a permanent, proprietary, optically responsive active ingredient that transforms ambient light energy and energy emitted by the body into energy with a different wavelength that the body then can reabsorb. The body uses this reabsorbed energy in a biological process known as the Krebs cycle, which converts acetate into carbon dioxide and water, relaxing capillaries and releasing energy. This release leads to increased oxygen levels, accelerating muscle recovery and building strength - attributes that aid in relieving pain associated with blood circulation loss caused by hardening of the arteries in diabetes sufferers. According to Robert Klein, inventor of Holofiber and chairman, Holofiber LLC, wearing Holofiber products can help lessen this condition.
Members of Team Holofiber have worn shirts, socks and long underwear made with Holofiber® during competitions. Tights, leg and arm warmers, hats and bike jerseys are currently in production.
Sound a little hard to believe? A double-blind clinical study conducted by Hologenix early last year found there was a "statistically significant change in transcutaneous oxygen - or the oxygen delivery to the skin - in hands and feet, on subjects wearing Holofiber gloves and socks compared to those wearing comparable non-Holofiber gloves and socks." The study also concluded that the 8- to 10-percent increase found in the participants' skin oxygenation could increase circulation enough to quicken wound-healing or eliminate ischemic leg pain often found in patients suffering from diabetes and vascular afflictions.
According to the company, Holofiber is not an applied additive or coating, but rather is a nontoxic, biologically safe material embedded in the fiber - meaning it won't wash or leach out of a fabric. This makes it extremely suitable for apparel.
The company has introduced Holofiber to the sportswear market, partnering with such companies as Canada-based Arriva - producer of Holofiber socks that target deep vein thrombosis, diabetes, sore and tired feet, circulatory impairment, neuropathy, early-onset varicose veins and injury recovery. Hologenix also has teamed with Wickers America Inc., Commack, N.Y., a manufacturer of Holofiber glove liners, boxers, socks and tights; Superfeet, Ferndale, Wash., a manufacturer of custom and trim-to-fit insoles; and Accumed Technologies, Buffalo, N.Y., a manufacturer of medical support wraps.
Athletes such as Olympic medalist triathlete Michellie Jones, and members of Team Holofiber - a co-ed Canadian adventure racing team that participates in endurance competitions that include running, mountain climbing, biking and canoeing - have found that Holofiber apparel has made a difference in energy and performance levels.
"I train about three hours a day, but no matter how much training I do, it is no comparison to a five-day nonstop race," said Lawrence Foster, captain of Team Holofiber. "It has always been a simple fact that you get sore and stiff if you stop and start intense physical exercise. In the recent Subaru Primal Quest [an endurance competition covering 400 miles in five to 10 days], our team would paddle 80 kilometers (km), run 40 km, then bike another 80 km, then stop for a two- to three-hour rest, sleep, and then do it all over again.
"The one thing we did differently [in this race] was change into our Holofiber clothing during those resting periods. When we woke up - no pain, no stiffness. We were ready to race again. The socks we wore were even better. My feet swell almost a full size during a long race, but we used Holofiber socks from Arriva and had little swelling and no blisters," Foster added.
Hologenix plans to develop many more applications for the responsive fiber. "In the next four or five years, Holofiber will be everywhere from medicine to fashion," Klein said. "It will also go into seating - Holofiber makes seats much more comfortable."
Saving Lives: Smart Medical Textiles
A variety of research institutes and programs around the world are working to develop the next breakthrough medical textile.
Tilak Dias, Ph.D., and Bill Cooke, Ph.D., of the William Lee Innovation Centre, England, are working to develop a "polymeric fiber-based wearable device platform through which [they] aim to launch a plethora of soft, electronic-embedded wearable computing devices." The researchers ultimately hope the intelligent health garment will integrate sensor arrays, conductive pathways and an intelligent signal processing system to enable real-time personalized information monitoring and measuring. Application possibilities include intelligent protective gear for the military, and intelligent garments for emergency medical technicians or their patients.
The center also is working on the development of engineered compression arm sleeves for chronic large-arm lymphoedema and engineered compression garments for venous disease.
Italy-based Smartex S.r.l. currently is developing a wearable health-monitoring system through its WEALTHY program. Backed by funding from Milior S.p.A., Lineapiù S.p.A., Ermenegildo Zegna S.p.A., Virginia-Antea Gestioni S.p.A. and Gabbiano S.p.A. - all based in Italy - Smartex aims to produce a fitted, stretch garment featuring a network of wireless communication sensors that are capable of remote transmission of vital signs to a health professional.
Smartex hopes the garment will aid patients in rehabilitation, assist medical technicians during risky activities, and alert emergency personnel if critical signals are received, among other goals.
An emergency data jacket developed by Wolfgang Röckelein, Ph.D., at the University of Regensburg, Germany, recently has been commercialized for use by emergency medical personnel.
The jacket - used currently by emergency physicians in Bavaria during rescue operations - allows a physician to use an embedded computer to record patient data onto a handheld computer, and then, using wireless technology, to transfer the data to the ambulance, rescue control center and hospital. The jacket also features a specialized interface that allows injuries to be photographed and transmitted; as well as a chip card reader that can store important medical and insurance information for retrieval by a doctor or administrator upon admittance to an emergency facility.
The Great Debate:
Disposable Versus Reusable Barrier Fabrics
A hot topic in the world of medical textiles is whether disposable barrier fabrics are better than reusable barrier fabrics. Proponents for disposable fabrics claim that using them lessens the chance of contracting an infectious disease or blood-borne pathogen because the item is destroyed after a single use. Others contend the technology necessary to make reusable barrier garments practical and safe - such as the ability to wash and resterilize a garment after each laundering - is not up to sufficient standards.
According to "Taking Cover: Single-Use versus Reusable Gowns and Drapes," an article in Infection Control Today®: "Single-use products are sterilized once; reusables are sterilized multiple times. Additional contamination between washings can increase the sterilization failure rate if not properly taken into account at the time of sterilization. Single-use products are sterilized in a manufacturing setting; reusables are sterilized in hospitals or laundry services. Certain manufacturers are regulated more stringently than laundry services, therefore, manufacturing settings may maintain more stringent control than hospital and laundry services."
Proponents of reusable barrier fabrics, on the other hand, point out that disposable garments lead to unnecessary waste. Fabrite® Laminating Corp., Woodridge, N.J., produces reusable barrier fabrics for the medical industry. It believes: "[R]eusable textiles offer a means to control the increase in health care costs that currently challenge our society. They provide the highest level of liquid barrier protection and are institutionally launderable, thereby being a part of the solution to some of our waste conservation issues."
Sean Manne, an advocate of reusable fabrics such as those coated with HaloShield, believes the cost-savings associated with being able to reuse the material for the life of the fabric are a big plus for many customers. "The life of the article is something that's very important and definitely saves the hospital or healthcare facilities money along the way," he said.
Barriers To Entry
Medical textiles is perhaps one of the few segments in the textile market that currently are not significantly affected by foreign competitors such as China. The industry does, however, suffer from lengthy development and clearance times because of the rigorous government clearance procedures necessary in the United States to bring a product to market.
According to Louis C. Franconi, new business development, Bally Ribbon Mills, the medical textiles market, and Bally in particular, is doing very well because it is so specialized. "There is a very big need for absorbable materials," he said.
The CorCap Cardiac Support Device from Acorn Cardiovascular Inc.
Bally's new product development team often works with customersto develop new medical textile implantables. Much of its medical device business stems from this custom work, and it can take months to bring a finished product to market. Franconi said his new development team will take a customer's idea, develop the necessary medical device, then give the device back to the customer, who then turns it into a working prototype. This cycle may happen several times in the development process, as the team and customer work to get the finished product just right.
Vanson HaloSource's HaloShield coating technology for barrier fabrics went through almost six years of research, development and clinical trials before enteringthe market.
The CorCap Cardiac Support Device from St. Paul, Minn.-based Acorn Cardiovascular Inc. also has faced similar barriers. Targeted to patients with heart failure, it comprises a mesh sock that encases the heart to help prevent or heal structural changes. The device has been in development for more than two years. The company expects to file a marketing application with the FDA by early next year.
Making Medical Textiles
Italy-based Matec, Belgium-based Europlasma NV and H. Stoll GmbH & Co., Germany, are just three of the textile machinery manufacturers that target equipment to the medical textiles sector.
The electronically controlled Pendolina Super knitting machine from Matec is designed to produce men's and women's medical garments with a reciprocated heel and toe. It is available in five different diameters, from 4 inches to 6 inches, and can work with any type of yarn or elastomeric fiber. The Pendolina Super features four single-cylinder feeds, four-needle selection points, step motors that control retractable stitch cam blocks, a vertical motorized dial arm with nine height positions, and a motorized circular cutter, among other features.
Europlasma NV’s CD Roll 1100 large-roll treater
Europlasma is a manufacturer and supplier of the CD Roll 1100 large-roll treater that applies the company's plasma technology to wovens, nonwovens and film products up to 1,800 millimeters in width. The machine was designed with such end-products in mind as blood filters and air filters. Treatments include barrier antimicrobial performance coatings on films and textiles.
Stoll fully automatic flat knitting machines are capable of efficiently producing support braces, stump socks, textile implants, spacer fabrics for use in straightening weak joints or muscles, and compression stockings for the treatment of lymphatic and blood vessel disorders and hypertrophic wounds.The company also offers customization services for producing highly elastic, knitted-to-fit articles.