MedTech Outlook Magazine: Specials Magazine

Clot extraction (thrombectomy) is a critical procedure for stroke patients, achieving technical success rates above 90 percent. However, while thrombectomy effectively removes the clot, it does not address the underlying damage to the brain tissue caused by one, the disrupted blood flow to the brain (ischemia) from the blockage of the brain artery by the clot and two, the secondary damage caused by reperfusion injury. Reperfusion injury is caused by the sudden inflow of blood following the reopening of a clogged brain artery and is largely an inflammatory response accompanied by oxidative stress that exacerbates brain damage. As a result, less than 20 percent of patients experience a full recovery. Therapeutic hypothermia is a well-known neuroprotective strategy that slows metabolism and reduces cell death through multiple protective mechanisms. Yet, systemic (whole body) cooling in stroke patients is often too slow and carries risks such as shivering, cardiovascular instability, infection, and immune suppression. In fact, it typically takes many hours to reduce body and brain temperatures by a few degrees Celsius—a complex undertaking which is often unsuccessful. These limitations make it impractical as a neuroprotective treatment for stroke. In contrast, selective endovascular brain cooling offers a promising alternative by delivering rapid, targeted hypothermia directly to the affected brain tissue. This method achieves protective brain tissue temperatures within minutes without compromising overall body function or introducing widespread systemic complications. Hybernia Medical is positioning itself at the forefront of this innovative approach. The company has developed a catheter-based system designed to provide localized brain cooling immediately following thrombectomy. This solution works within minutes, cooling the targeted brain tissue directly through a catheter introduced via the same arterial pathway used during clot extraction. “We developed a device that cools the brain directly through a catheter system in a highly selective, precise, and fast manner,” says Jae Choi, co-founder and CEO. The approach is built on years of rigorous research and development, evolving through extensive tests and large-animal studies and building on numerous preclinical stroke experiments that have validated both its safety and feasibility. Early clinical signals suggest that when combined with thrombectomy, localized cooling could lead to significantly improved outcomes. Beyond the cooling mechanism itself, Hybernia Medical’s system is engineered with advanced technology to ensure optimal performance. Embedded sensors provide real-time feedback that allows the device to adjust dynamically to the patient’s anatomical and physiological environment. This intelligent design ensures that the cooling process is not only effective but also consistent and safe. The infusion system that drives the cooling process has been optimized for maximum efficiency by using minimal fluid volumes—down to a fraction of a milliliter—which enhances heat transfer at the tissue level without jeopardizing patient safety or causing systemic instability.

Chronic low back pain disrupts daily life, affecting physical comfort, emotional well-being, and social interactions. However, managing it often involves difficult decisions—such as undergoing surgery or relying on opioids and prescription painkillers. Neither option offers a reliable solution, especially amid growing concerns about inadequate pain relief and addiction. Addressing this urgent need, healthcare now demands an effective, all-in-one approach—one that alleviates chronic pain while preventing opioid use. Harmonic Scientific rises to the challenge with the first non-invasive therapy designed as both an alternative to starting opioids and a treatment to restore normal function—providing lasting relief. Beyond physical comfort, it offers a breakthrough solution for those seeking safer, more effective pain management. “Our non-invasive device was specifically designed to replace opioids in the office or emergency room, offering multimodal pain management without medication. Since we began our research, our technology has also been found to reverse the cause of inoperable mechanical chronic pain—making it a comprehensive solution,” says Amy Baxter, CEO. A Non-Invasive, Drug-Free Approach Low back pain is the leading cause of disability and a major driver of non-cancer outpatient opioid prescriptions. Harmonic Scientific addresses this issue with surgery-free and drug-free therapies, leading the way in pain management. As a National Institutes of Health (NIH)-funded company and a spinoff of Pain Care Labs, it effectively incorporates mechanical stimulation (M-Stim^®) with thermal therapies to deliver optimal pain relief through non-invasive devices. DuoTherm^™ integrates an array of vibrational frequencies that interact over a large area of the low back fascia and spine-supporting muscles. By combining heat, cold, and pressure with varying locations, frequencies, and amplitudes of M-Stim^®, DuoTherm^™ targets the spine, muscles, and fascia—accommodating people of different sizes and shapes. Given that no single pain treatment works for everyone, and that the source of pain evolves after an injury, DuoTherm^™ provides multiple recovery options, offering a crucial alternative to combat both pain and opioid initiation.

Peripheral vascular occlusions have traditionally been treated using two methods: open surgery or thrombolytic drugs (lytics). While somewhat effective, both carry significant risks. Surgical thrombectomy is a procedure that often leads to surgical complications such as hematoma, blood loss, vessel trauma, and prolonged recovery. Lytic therapy is an easier therapy to prescribe, however it increases the risk of severe bleeding events, including intracranial hemorrhage, is limited for qualified patients, and presents prolonged delivery and recovery time which is extremely costly. Surgical and drug complications present risk, and today’s peripheral interventional solutions continue to have shortcomings while costs skyrocket. Physicians have long sought a safer, more efficient alternative that addresses today’s shortcomings while hospitals and our healthcare system continue to seek treatment options that address the economics in treating peripheral occlusions iCHOR Vascular was founded to address this gap. Co-founded by interventional radiologist Dr. Troy Long and medical device veteran Tim Blair, the company is transforming mechanical thrombectomy by returning to the fundamental parameters of surgical thrombectomy. Rather than building on existing technologies like aspiration and metal coring, iCHOR drew inspiration from the proven surgical Fogarty balloon technique, known for its effectiveness in surgical clot removal. The team modernized this surgical technique into a minimally invasive solution with the iSWEEP platform. “Our goal was to bring the predictability and reliability of surgical clot removal into a minimally invasive system,” says Blair, CEO of iCHOR. “Physicians understand how a compliant balloon works, we simply wanted to give them that same control without the surgical complications. Patients can avoid drug and surgical complications and go home sooner which is good for the patient, the treating physician, the hospital ICUs, and our healthcare system.” A Surgical Concept, Reimagined for Endovascular Care The iSWEEP system offers circumferential wall apposition, enabling a compliant balloon to engage the clot along the entire vessel wall—something that aspiration and other systems fail to achieve consistently. The iCHOR iSWEEP systems have recently demonstrated quick procedure times, no adverse events, no blood loss, and no post-procedure thrombotic issues at 30 days. The iCHOR systems completely eliminate the need for thrombolytic agents, surgery, and because there is no capital equipment; many of these patients are now being treated in same-day surgery settings. Tailored to the complexities of peripheral vasculature, the iSWEEP systems are designed to effectively handle both arterial and venous thrombus. Many patients present with long clot segments in tortuous anatomy—areas where traditional aspiration or power-based systems struggle. The iSWEEP catheter navigates large and small vessel areas with ease, utilizing a balloon-based design that gently sweeps the clot toward a guide sheath for safe removal. All of this replicates the elements of an open surgery but without a cut down on the skin or a vessel. The iSWEEP family includes two specifically tailored devices: iART, a 7F system optimized for arterial clot removal, and iDVT, a 14F system designed for venous clot removal. Both devices leverage the same innovative balloon-based design, offering physicians a versatile and reliable solution for treating both arterial and venous thrombotic conditions with a single device, ensuring precision and efficiency across varying types of morphology and anatomy.