Ariste is presently developing a drug eluting mesh for hernia repair, a drug eluting tunneled dialysis catheter for hemodialysis, and a drug eluting vascular graft for peripheral bypass. Each of these drug eluting products helps to address common causes of device failure, such as infection, thrombosis and restenosis. Adding drugs to these devices will help preserve their function, and ensure that patients have the best opportunity for a successful outcome.
Ariste has developed a novel method of eluting drugs from the surface of ePTFE, the most slippery surface known to exist. Ariste’s technology will enable the development of a new class of drug-eluting devices that may improve patient outcomes in common vascular procedures, including hemodialysis access, peripheral bypass and hernia repair. Ariste is presently developing a drug-eluting tissue patch for hernia repair, a tunneled dialysis catheter for hemodialysis, and a drug-eluting vascular graft for peripheral bypass procedures.
This methodology also applies to other materials, such as polypropylene and polyurethane.
Why is this important? ePTFE, better known as GoreTex®, has been a preferred materials for medical implants since the 1970’s. Today, this material is commonly used in millions of vascular procedures annually throughout the world, such as hernia repair, peripheral bypass, and hemodialysis access. However, these devices commonly fail due to infection, restenosis (scar tissue formation occluding the device), and thrombosis (blood clot occluding the device).
Because ePTFE is both inert and exceptionally slippery, it has been a challenging surface to work to modify and little change has occurred to ePTFE devices in the past 40 years. Ariste’s patented formula enables transformation of legacy implantable products into a new class of drug-eluting devices. We can now deploy implantable devices that can deliver antibiotic agents to prevent infection, antiproliferative agents to prevent restenosis, and antiplatelet agents to prevent thrombosis, thereby reducing device failure, improving patient outcomes, and reducing unnecessary healthcare expenses associated with repeat operations.
Importantly, as the formulation works well with ePTFE, it is also applicable to a variety of other materials. As a result, Ariste is also developing drug-eluting devices that are made using other materials, such as polypropylene and polyurethane.
Drug eluting mesh for hernia repair
Hernia repair is among the most common surgical procedures in the US with over 1,000,000 procedures performed annually. “Open” repair with mesh implantation is often required and the risk of infection is high and results in excess morbidity and costs. The most common pathogen associated with infection of hernia mesh is methicillin-resistant staphylococcus aureus (MRSA), responsible for 63% of mesh infections (Falagas ME, 2004). Treatment usually requires reoperation and removal of the infected mesh is often necessary. The additional costs and increased morbidity associated with infected hernia mesh have been well documented.
Zone of inhibition testing comparing standard hernia mesh to Ariste drug eluting hernia mesh after 7 days using MRSA. Bacteria have overrun the standard hernia mesh while the antibiotic eluting mesh remains free of bacterial colonization.
Drug eluting tunneled dialysis catheter for hemodialysis
At the start of dialysis 82% of patients receive a tunneled dialysis catheter, which suffers from infection, thrombosis, and central vein stenosis. In the US, we spend over $1 billion each year just to maintain vascular access for patients that require hemodialysis. When vascular access can not be sustained, patients die. Each year 25% of deaths among the hemodialysis population are due to loss of vascular access.
The Ariste drug eluting tunneled dialysis access catheter will offer a combination of anti-thrombotic and anti-infective drugs to help prevent device failure from both clotting and infection.
Scanning electron micrography of uncoated and coated grafts in vitro after 24 hrs in S. epidermidis broth. There is a large amount of bacteria on the uncoated ePTFE (top) and almost no colonies on the antibiotic eluting ePTFE (bottom).
Drug eluting vascular graft for peripheral bypass
Ariste is developing a drug-eluting vascular graft that will carry a proven mTOR-inhibiting agent. These drugs have demonstrated success in the coronary setting (drug eluting stents) where reductions in restenosis correlated to reduced need for re-intervention in the first year. Using sufficient drug to target only the surgical anastomoses, Ariste has already demonstrated proof-of-concept in a porcine model. In this model, 22 pigs were randomized to receive a control graft, a graft containing the adhesive polymer only, and the Ariste drug-eluting graft. As shown in the charts below, significant improvements in measures of neointimal hyperplasia (scar tissue development) were observed, which can be seen readily with the naked eye in the pictures to the right. Additionally, we examined the grafts to determine if the Ariste graft impeded the natural healing process, and found that re-endothelialization was similar between the control graft and the Ariste drug-eluting graft.
Ariste thinks that the development of its drug-eluting grafts for peripheral bypass will have a significant and positive impact on the lives of patients that require such procedures to preserve blood flow to their limbs.