“The evolution toward minimally invasive procedures is now well entrenched, and outcomes have established endovascular techniques as the standard of care in most peripheral vascular and coronary procedures. While these interventions have generally been accepted as safe, there are still aspects that can be improved,” remarks Ravish Sachar, MD, FACC, founder and CEO of Contego Medical, a medical device company disrupting the field of endovascular medicine with its integrated embolic protection technology.
As the physician-in-chief of UNC-REX Heart and Vascular Service Line, Sachar is consistently exposed to the unmet needs of patient care and is well aware that with every intervention lies the possibility of embolization. As an example, carotid stenting has become a valuable alternative approach to carotid endarterectomy for treating carotid artery disease. While the device used in this procedure employs filters to capture the released particles and protect the brain, there still exists a risk of procedural stroke due to the small embolic particles, which still manage to get through.
Contego Medical’s proprietary technology platform, Integrated Embolic Platform (IEP) is capable of mitigating the risk of stroke further, specifically during the most vulnerable phase of carotid stenting procedures known as post-dilation, without adding more complexity or procedural time. The IEP technology is unique since it incorporates filter-based embolic protection directly onto the treatment device. “We developed our first IEP device, the Paladin® Carotid Post-Dilation Balloon System, with an integrated micro-embolic filter and have continued to build on our platform in devices targeted for multiple vascular beds,” states Sachar. The single-step system integrates a post-dilation balloon proximally and embolic protection filter at the distal catheter tip. The filter provides better wall apposition and can adjust its diameter to suit a patient’s anatomy. It features 40-micron pores which are smaller than currently available devices, and thus captures the smaller particles responsible for the higher risk of minor stroke seen during carotid artery stenting.
Our cutting-edge products with
IEP technology add a measure of
safety that allows physicians to treat
complex patients while lowering the
risk of complications
In a study involving 106 patients who were treated with the Paladin device, there were no procedural strokes, which represent best-in-class data when compared to similar carotid stenting studies. Sachar mentions how a physician from Europe stated that without Paladin, he would not have been able to treat a 37-year old patient having a stroke. “Similarly, with our Vanguard IEP System, designed for use in the lower extremities, a physician commented how a patient with thrombus in his legs on whom he used the device, would have otherwise faced a higher risk of embolization and amputation,” he adds.
Contego Medical’s IEP products are designed for the needs of each target anatomy, creating seamless protection while maximizing performance. The company is always looking for new solutions that improve the safety profile and reduce the complexity of endovascular procedures. “Our biggest advantage is our culture, which is to push the boundaries and not accept the limitations typically experienced by other companies,” says Sachar. Contego Medical has a steady pipeline of devices in development and commercialization planned over the next four years. In addition to expanding product development, the company intends to increase its market presence by targeting markets beyond Europe and U.S., such as Brazil, Australia, and Japan.
Recently, Contego Medical initiated its PERFORMANCE I trial for patients in Europe to evaluate device safety and performance of its Neuroguard 3-in-1 Carotid Stent and Post-Dilation Balloon in carotid stenting. The company’s latest offering features a next-generation optimized nitinol stent and angioplasty balloon as well as a 40-micron filter, all on one catheter. “Our cutting-edge products with IEP technology add a measure of safety that allows physicians to treat complex patients while lowering the risk of complications,” concludes Sachar.
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