To improve patient comfort and to eliminate revision surgeries caused by infection or other complications, surgeons prefer simple operating procedures that use advanced technology and innovative biomaterials. Frost & Sullivan estimated the U.S. biomedical textiles market to be worth $300.2 million in 2016; it is projected to reach $447.8 million by 2020.
Biomedical textiles are natural or synthetic materials, including polymers or metals, used in medical devices and implants. Frost & Sullivan estimated the U.S. biomedical textiles market to be worth $300.2 million in 2016; it is projected to reach $447.8 million by 2020. The rising incidence of age-related disorders and lifestyle-related chronic diseases among younger people are driving the demand for cardiovascular, orthopedic and urological implants and for biomaterial textiles.
Novel biomaterials are being developed to offer better tensile strength, mechanical stability, flexibility, durability, fatigue resistance and biocompatibility, and a more effective surface area. Some of the innovations are described below.
To limit the chance of infection after an implant, especially among patients with diabetes or ascites, device manufacturers are developing hernia meshes with dual-surfaced biomaterial and with anti-microbial agents that can elude drugs from the mesh surface. W.L. Gore’s DualMesh® Plus features anti-microbial agents (chlorhexidine diacetate and silver carbonate) and an advanced tissue ingrowth surface. This technology is in the clinical phase. Ariste Medical is developing a method of eluting drugs from the surface of expanded polytetrafluoroethylene (ePTFE). Its patented formula enables deployment of implantable devices that can deliver antibiotic agents to prevent infection, anti-proliferative agents to prevent restenosis, and antiplatelet agents to prevent thrombosis. These features can reduce the device failure and improve patient outcomes, in turn reducing unnecessary healthcare expenses associated with repeat operations.
Soft-Tissue Support Mesh
Companies are developing synthetic support meshes with enhanced flexibility for surgical procedures, higher mechanical stability to bear load and offer long-term support, and superior biocompatibility to prevent rejection. C.R. Bard, Johnson & Johnson, and Medtronic are among the companies that are enhancing their product lines. The use of biologic grafts from human cadavers (allografts) and non-human sources (xenografts) is an emerging trend. Collagen, an important component of soft tissue, is abundant in mammals; tissue from these sources performed better than synthetic soft-tissue mesh.
Biodegradable polymers such as polyacrylamide, poly(lactic-co-glycolic acid) and polycaprolactone have eliminated the need for repeat operations to remove stents because the materials either degrade or dissolve. Another notable technological advancement in this is self-expanding stents that can be deflated/collapsed to pass through narrow areas and expanded upon reaching the application site. Apart from their innovations in biomaterials and self-expanding stents, Boston Scientific, Abbott Vascular and Medtronic are conducting research in the use of antimicrobial coatings and anti-restenotic drugs on stents to prevent infection and blood coagulation.
Vascular Stent Grafts
Vascular stent grafts are implants used in supporting weak spots in an artery, known as aneurysms. The conventional implantation technique, which was an open surgical procedure, has been replaced with minimally invasive techniques through endovascular stent grafts: only a small incision is made in the application area. Lombard Medical has developed Altura, an endovascular stent graft to treat abdominal aortic aneurysms, which received the European CE mark in 2015 and is in clinical trial stages in the United States. The product allows for repositioning during deployment and accurate graft placement at each renal artery; it eliminates the need for cannulation and results in simple, safe and consistent deployment with shorter, predictable procedure times that ultimately reduce physician and patient X-ray exposure time.
Regeneration of small-diameter blood vessels has been a challenge because of their structural complexity and dynamic functions; companies have been focusing on innovations in vascular grafts of less than 6 mm. Nanofibrous, multilayered grafts composed of copolymers with innovative biomaterials are among the latest technological advancements. The use of combined polymers results in layer-by-layer enhancement of properties related to fiber diameter, suture retention, and biocompliance. Boston Scientific, W.L. Gore and Maquet have made progress in this area.
Researchers at the University of Maryland are developing 3-D biodegradable vascular grafts with a focus on congenital heart defects, which affect about 1% of newborns each year in the United States. The vascular graft is tri-layered with a biocompatible and biodegradable polypropylene fumarate for a robustness that conventional vascular grafts lack.
Urology/Pelvic Sling Implants
Manufacturers in this space are enhancing products to reduce procedure time and hasten healing. Boston Scientific, for example, is designing a pelvic sling implant that cuts surgery time to 30 to 45 minutes and offers a recovery time of 2 to 4 weeks with minimal side effects.
Transcatheter Heart Valves
Transcatheter heart valve replacement, a minimally invasive procedure, can improve recovery time by minimizing the incision site and reducing tissue damage and infection. Biomaterials used in this segment are engineered as tubular knits/woven/high covering braided biomedical structures made of polyester fibers that can withstand stress and fatigue. The technological advancements in this area are aimed at addressing clogs in blood flow, time lags in deployment of the implant device, and cross clamping. Edward Lifesciences and Medtronic have solutions that are in the clinical trial stages.
Sports Medicine Suture Anchors
Innovations in this space focus on minimally invasive procedures that promote fast recovery and long-term comfort. Smith & Nephew has launched several products, including Suturefix Ultra soft suture anchor, used in hip and shoulder labral repair for higher fixation strength; Healcoil Regenesorb Suture Anchor, which uses the company’s proprietary biocomposite material Regenesorb that is clinically proven to be resorbable and replaced by bone within 24 months; and Q-Fix™ All-Suture Anchor, used in hip labral repair to provide better flexibility and ease knot deployment.
Open Surgery Heart Valves
The development of these devices is driven by patient demand for less-invasive heart surgery. Companies are focusing on minimally invasive surgery techniques that improve smooth valve delivery and handling. For example, St. Jude Medical recently launched its Trifecta™ Valve with Glide™, designed to mimic the function of a natural, healthy heart valve with improved features such as ease of placement for challenging anatomies, enhanced valve delivery, a streamlined valve holder for improved visibility, and features for future interventions.
Absorbable Hemostats/Fibrin Sealants
Excessive bleeding occurs during some cardiovascular, orthopedic, neurological and vascular implant procedures; hemostats with a higher and quicker absorption rate have been required. Ethicon (Johnson & Johnson) and Baxter are among the companies researching the use of non-woven or knitted dense textile structures for better strength and better surface area for coverage during heavy bleeding.
What’s the Future?
To improve patient comfort and to eliminate revision surgeries caused by infection or other complications, surgeons prefer simple operating procedures that use advanced technology and innovative biomaterials. Companies are expected to focus on identifying novel biomaterials based on polymers and biologics to limit the need for repeat operation, support faster recovery, and prolong patients’ quality of life.
Copyright © 2017 Frost & Sullivan