Catheter related thrombosis

SUZHOU, China, Nov. 29, 2023 /PRNewswire/ -- Earlier this month, magAssist Co.,Ltd. ("magAssist" and "the Company"), a leading medical developer of extracorporeal life support devices in China, attended the 29th annual meeting of the International Society for Mechanical Circulatory Support (ISMCS) as a corporate member. The conference, held in Dallas, Texas, from October 30 to November 1, 2023, served as a crucial platform for scientific exchange in the field of mechanical circulatory support, and saw magAssist introduce its latest innovation – NyokAssist – an interventional ventricular assist device which has completed its first-in-human (FIM) procedure in China this August. Held once a year, the ISMCS gathers global experts and scholars in the circulatory mechanical industry under the same roof, fostering collaboration to explore research, development, clinical applications, and social acceptance of rotary blood pumps and related mechanical circulatory support systems. It aims to help develop technologies, applications, and clinical procedures for rotary blood pumps and associated systems, enhancing the life quality for recipients and ensuring cost-effective access to emerging therapies. ISMCS is also a supporter of the world's first competition dedicated to artificial heart design, Heart Hackathon, which is sponsored by MedTech industry leaders including magAssist that help catalyze cardiovascular innovation. During the meeting, magAssist showcased how the company's latest technological breakthroughs bridge the clinical gaps and address the unmet medical needs of patients suffering from severe heart diseases. Dr. Thomas George Logan, magAssist's Chief Engineer and Chief Scientist, who was also one of the juries of the Heart Hackathon, has provided updates on the groundbreaking innovations of magAssist's product NyokAssist. NyokAssist: The New Generation of Interventional VAD Earlier in August, NyokAssist completed its first-in-man procedure. The FIM use of NyokAssist which supports high-risk percutaneous coronary interventions (PCI) was completed by Dr. Junbo Ge and his colleagues from Zhongshan Hospital in Shanghai, with the procedure performed on a man in his 40s with coronary artery disease, heart failure, type II diabetes, and post-PCI. Given the patient's high surgical risk, Dr. Ge's team decided to perform PCI with NyokAssist, which delivered a safe and effective result throughout the procedure, providing an average flow of more than 3L/min and maintaining stable blood pressure. The patient was discharged two days later. (Note: The patient's information has been authorized by the patient's consent and has been anonymized to ensure the protection of individual confidentiality.) Marking a new milestone for magAssist, NyokAssist's successful FIM procedure follows the announcement that the device has received U.S. Food and Drug Administration (FDA) Breakthrough Device designation, a recognition that underscores the pioneering features of NyokAssist and reconfirms magAssist's position as a pioneer in the landscape of advanced medical devices. MoyoAssist ： A Lifesaving Solution for Heart Failure Patients Also participated as one of the corporate delegates, IFan Yen, the Vice President of magAssist R&D Department, addressed the unmet medical needs for patients suffering from severe heart diseases and provided latest updates on MoyoAssist Extra-VAD. "Cardiovascular diseases claim over 17.9 million lives annually, representing over 30% of global deaths, exceeding 40% in China, according to the World Health Organization. In response to this significant health challenge, we developed our first high-tech Class III product, MoyoAssist Extracorporeal Ventricular Assist Device, which offers reliable, lifesaving alternatives for heart failure patients with better clinical outcomes," said IFan. Equipped with a disposable pump head, full maglev motor, and a portable console, MoyoAssist can offer up to 30 days of support time, designed for patients with AMI-CS, PCCS, BTT, and Bi-ventricular heart failure. The device harnesses advanced computational fluid dynamics and full maglev technology to achieve optimal hemocompatibility, significantly reducing the risk of device-related thrombosis, coupled with an advanced flow path design that provides effective perfusion of all the organs for MODS patients. "It is an honor for magAssist to be a corporate member of ISMCS and the industry partner of Heart Hackathon that fuel transformative changes in the field. As a MedTech innovator that strives to empower healthcare professionals to offer better treatments to patients with state-of-the-art technology and services, our mission aligns with the aims of the two events through which we aspire to further ignite inspiration for the next-gen lifesaving solutions," said IFan. "At the core of magAssist's mission and industry standing lies a deep commitment rooted in cardiac care. Since its establishment, magAssist has remained dedicated to advancing medical technology and has applied for over a hundred patents, propelling the development of medical technology through innovation, research, and patient-centric solutions. In pursuit of creating a multi-organ support platform that allows global patients to access cost-effective and high-quality treatments, we continue to bring more value for healthcare professionals and the medical device industry as a whole," IFan added. To learn more about magAssist product updates , please visit: magAssist's NyokAssist™️ granted Designation by the FDA as a Breakthrough Device (prnewswire.com) First Patient with NyokAssist™ Interventional Ventricular Assist Device: Dr. Junbo Ge's team successfully completed the first high-risk PCI treatment supported by the new generation of interventional VAD (prnewswire.com) MoyoAssist® Extra-VAD, a Promising Solution for Short-to-Medium-Term Ventricular Assist for China NMPA trial, Showcased at 4th Academic Annual Conference of CSBE (prnewswire.com) About magAssist magAssist is one of the leading medical device companies in the healthcare industry, focused on developing circulatory support devices for acute/severe cardiac and pulmonary failure. Our products include extracorporeal ventricular assist device (extra-VAD), interventional ventricular assist device, extracorporeal membrane oxygenation systems (ECMO), and organ care systems. Our first product MoyoAssist Extra-VAD has completed clinical trials in China. NyokAssist Interventional VAD, the innovative product, has been designated as a breakthrough device by the FDA. Moving forward, magAssist is dedicated to providing valuable technology for patients and clinicians worldwide. Disclaimer: magAssist products have not yet received approvals from either the U.S. FDA or China NMPA at this stage. The content is intended solely for informational purposes, with a focus on providing information including industry and academic exchange. It is not intended for advertising and should not be considered as an advertisement, either explicitly or implicitly. Nor shall it be considered for any purpose of offering to sale or sale. For precise information, please seek guidance from a healthcare professional. SOURCE magAssist Co., Ltd

Study Published in the Journal of Materials Science: Materials in Medicine Shows Benefits of Novel Catheter Technology BILLERICA, Mass.--(BUSINESS WIRE)-- Access Vascular, Inc. (AVI), a medical device company addressing the most common and costly complications of intravenous therapy, today announced the publication of a peer-reviewed study of its HydroPICC® peripherally inserted central catheter (PICC) in the journal Journal of Materials Science: Materials in Medicine. The retrospective study demonstrated that HydroPICC significantly reduced clot formation and failures, compared with conventional polyurethane PICCs. Of the estimated 2.7 million PICCs placed in U.S. patients each year, roughly 95 percent are made from polyurethane, with occlusion rates ranging from 7.4 to 35 percent – meaning that there are hundreds of thousands of polyurethane-related PICC occlusions each year in the U.S. alone. This retrospective study investigated whether the HydroPICC, constructed of a novel hydrophilic biomaterial with MIMIX™ technology, reduced thrombotic catheter occlusions, compared to polyurethane devices, in 121 patients who received a PICC as part of their medical care. The study results demonstrated no occlusions or replacements in the 60 HydroPICC insertions, while 13 catheter occlusions were reported in the 61 polyurethane insertions catheter group and eight outright PICC replacements (13%). “Reducing clot formation in PICCs helps to reduce delays in treatment, unscheduled catheter replacements, the risk of infection, and overall total cost of medical care,” said James Biggins, co-founder and CEO of Access Vascular, Inc. “If we conservatively project out the cost savings on just replacement devices seen in this study, there could easily be an annual savings of $80 million in the U.S. – and, most importantly, greatly improve the standard of care for patients.” AVI’s platform of biomaterial-based vascular access devices, featuring MIMIX™ technology that mirrors the body’s chemistry, is designed to help reduce the most common and costly complications associated with vascular access procedures: infection, thrombosis, and phlebitis. Recently published clinical data for the HydroMID midline catheter showed six-fold failure reduction compared with a standard polyurethane device. “This study validates the dramatic reduction in complications I’ve seen since switching to Access Vascular’s devices, and I’m excited to share these results with the greater clinical community,” said Joseph Bunch, RN, lead author of the study. “Innovations, such as AVI’s clot-resistant technology, which help patients and clinicians alike by improving the standard of care, should be widely adopted by healthcare practitioners.” About Access Vascular Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a hydrophilic material which retains significant amounts of water. Engineered to mimic the body’s natural chemistry, Access Vascular catheters are designed to evade the foreign body response and complications that come with it. Our award-winning, FDA-cleared products are HydroPICC® and HydroMID®. For more information, please visit .

Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive. The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations. Medtronic, Abbott, Edwards and Boston Scientific represent a few of the companies revealing new data for their cardiovascular offerings. ReCor Medical, Abiomed and more got involved, too. Plenty of the study outcomes represented positive steps forward, while other companies hit speed bumps in their efforts. Here are some of the biggest takeaways from the conference: 1. Renal denervation innovations plug along Medtronic (NYSE:MDT) announced study data that demonstrates significant blood pressure reduction with the Symplicity renal denervation system. The RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. Results from the SYMPLICITY HTN-3 trial demonstrated a statistically significant reduction in office and ambulatory blood pressure compared to a sham control group. Questions arose last year when Medtronic announced that it had to continue its pivotal Spyral HTN-ON MED trial into this year. The trial failed to produce the positive results needed to end enrollment early for the potential hypertension treatment. However, analysts have remained bullish on Medtronic’s RDN treatment. Medtronic plans to present Spyral HTN-ON MED results at the American Heart Association Scientific Sessions this November. Spyral HTN-ON MED is the final piece of Medtronic’s FDA submission for Symplicity Spyral. In other renal denervation news, a trial for ReCor Medical’s Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint. ReCor’s CEO said the data is “further evidence that the Paradise uRDN System lowers blood pressure in a wide range of patients who are struggling to control their hypertension.” 2. TEER therapy competition heats up The CLASP IID pitted the Pascal device from Edwards Lifesciences (NYSE:EW) against the MitraClip from Abbott (NYSE:ABT). Edwards presented data just days after the FDA approved the Pascal system for transcatheter edge-to-edge repair (TEER) in patients with degenerative mitral regurgitation (DMR). Data from CLASP IID confirmed that TEER therapy is both safe and effective. The trial met its primary safety and effectiveness endpoints, according to a news release. Pascal also demonstrated non-inferiority for safety and effectiveness compared to MitraClip. “As one physician panelist put it, ‘It’s been a good day for TEER therapy,’” BTIG analyst Marie Thibault says. “We view CLASP IID as a clear success in showing PASCAL is safe, effective and commercially viable.” Thibault added that physicians at TCT cautioned against the direct comparison between the Edwards and Abbott devices. Despite the data’s slight skew toward Pascal, Abbott still presented positive data on its MitraClip system. Abbott shared post-approval study results supporting its MitraClip G4 system for treating mitral regurgitation (MR). Data from more than 1,000 patients confirm that MitraClip offers high success rates in terms of MR reduction. It also demonstrated improvements in quality of life and low adverse event rates. “MitraClip provides long-term, significant mitral regurgitation reduction that changes and saves lives,” said Michael Dale, SVP of Abbott’s structural heart business. 3. TAVR studies see mixed results Medtronic kicked off TCT by announcing the full U.S. launch of its next-generation Evolut FX transcatheter aortic valve repair (TAVR) system. It went on to present positive data from multiple trials supporting its transcatheter heart valve replacement devices. The Pathological Study of Hypo-Attenuated Leaflet Thickening (HALT) represents part of the CoreValve and Evolut TAVR program. It compares microCT and histology findings of valve leaflet thickening. Medtronic said in a news release that the trial is the first to compare such things. It may provide clinical insights into the long-term durability of transcatheter aortic valves (TAVs) and the treatment of HALT. “As TAVR continues to grow as a treatment option for aortic stenosis, identifying pathological changes to TAVs over time is critical for understanding their long-term durability,” said Nina Goodheart, SVP and president of the Structural Heart & Aortic business at Medtronic. Elsewhere at TCT, Boston Scientific’s TAVR-related study failed to meet its primary endpoint. Boston Scientific designed the Sentinel cerebral protection system to capture and remove embolic debris stemming from TAVR. The aim is to extract the debris before it can reach the brain, potentially causing a stroke. Sentinel provides cerebral embolic protection (CEP) during TAVR. Data from the PROTECTED TAVR trial demonstrated a non-significant trend toward a lower rate of stroke in patients treated with Sentinel. Despite the missed endpoint, a secondary analysis of Sentinel demonstrated a statistically significant 60% relative risk reduction in disabling stroke through 72 hours or time of hospital discharge. Thibault said a physician panel at TCT still voted 7 to 1 in favor of using Sentinel when polled publicly. Dr. Ian Meredith, global CMO, Boston Scientific, said the company believes the data shows that Sentinel represents “an effective therapy to reduce the risk of the most debilitating form of stroke for patients undergoing TAVR.” 4. In the LAA closure fight, Amplatzer Amulet takes the latest round Abbott and Boston Scientific’s left atrial appendage (LAA) closure devices went head-to-head again. This time, Abbott came out on top. The company reported that device-related factors and all-cause death represented categories favoring its Amplatzer Amulet against Boston Scientific’s Watchman. Abbott reported three-year outcomes for the Amulet IDE trial. It found that device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Amulet. The company said cardiovascular and all-cause death trended higher in the Watchman device than in the Amulet device. Data from last year’s TCT demonstrated that Boston Scientific’s next-generation Watchman FLX stroke prevention device outperformed the Amulet device. Findings from the SEAL FLX study found that Watchman FLX demonstrated superiority in the area of LAA closure and peri-device leak. The battle between the two devices continues to be one to watch.