Intra-Abdominal Hypertension

JACKSONVILLE, Fla., Aug. 2, 2023 /PRNewswire/ -- In the face of the ongoing supply issues affecting Intra-Abdominal Pressure (IAP) transducer kits, Sentinel Medical Technologies is stepping up to ensure that patient care remains uncompromised. The company's FDA-cleared product, TraumaGuard, is now readily available to fill the gap left by the shortage of CR BARD or Centurion IAP kits. Continue Reading TraumaGuard Continuous Intra-Abdominal Pressure Monitoring System IAP monitoring is a critical component of patient care in OR and ICU settings. It serves as a crucial guide for medical teams in assessing the risk of developing Intra-Abdominal Hypertension (IAH) and Abdominal Compartment Syndrome (ACS), conditions that can have severe consequences if not addressed promptly. Given the critical importance of IAP measurements, the ongoing shortage of transducer kits has created obstacles for healthcare providers, increasing the barriers in delivering essential, life-saving care. TraumaGuard offers a solution to this pressing issue. More than a product, TraumaGuard is a commitment to patient care. It provides continuous, hands-free monitoring of IAP, Core Body Temperature, and bladder drainage in critical care patients of all departments. Once administered, TraumaGuard can be left in place for 30 days, eliminating clinical staff burden and improving workflow. Moreover, TraumaGuard's unique technology is designed with patient safety in mind. It actively detects advancement toward Abdominal Compartment Syndrome (ACS), sending proactive alerts to both bedside and nurses' stations while automatically recording and storing measurements in the existing EMR database. This allows for timely interventions that can prevent the escalation of negative patient conditions. In addition to its clinical benefits, TraumaGuard also offers significant cost savings. When actively deployed, it reduces the overall cost of patient care while requiring no capital equipment and can be connected to existing bedside monitors. This makes TraumaGuard a cost-competitive and equivalent replacement to existing IAP devices. Patrick Beer, DO, Critical Care Surgery Specialist, Hurley Medical Center, commented on the situation: "The availability of TraumaGuard comes at a time when IAP transducer kits are currently unavailable or discontinued. This shortage has been a major challenge for OR and ICU teams, who rely on IAP monitoring to assess the risk of Intra-Abdominal Hypertension (IAH) and Abdominal Compartment Syndrome (ACS)." Sentinel Medical Technologies is committed to ensuring the availability of TraumaGuard now and in the future. The company understands the critical role that IAP monitoring plays in patient care and is dedicated to ensuring that healthcare providers have the tools they need to deliver the best possible outcomes. For more information about TraumaGuard, please visit About Sentinel Medical Technologies: Sentinel Medical Technologies is a focused-leader in health technology, committed to saving lives with pressure monitoring. Founded with the mission to advance the standard of care, Sentinel offers a growing suite of innovative pressure-based monitoring devices that cater to a variety of disease states. By unlocking the power of data at the point of care, Sentinel delivers value-based healthcare solutions that are simple, efficient, and cost-effective. Our cutting-edge technologies are designed to solve unmet clinical needs, instill technological confidence in the workflow, and improve patient outcomes. SOURCE Sentinel Medical Technologies

▎药明康德内容团队编辑本期看点1. 西门子健康公司Corindus公布了其CorPath GRX神经血管系统进行机器人辅助神经血管动脉瘤栓塞手术试验的结果。2. Pixium Vision治疗萎缩性干性年龄相关性黄斑变性（干性AMD）的仿生视觉系统在意大利完成首位患者的植入。3. ONWARD Medical无创脊髓刺激技术的大规模临床研究达积极终点。4. 更多科技相关资讯。西门子健康公司Corindus公布其CorPath GRX神经血管系统进行机器人辅助神经血管动脉瘤栓塞试验的结果精密血管机器人开发商Corindus于近日公布了其开展的使用CorPath GRX神经血管系统进行机器人辅助神经血管动脉瘤栓塞手术的安全性和有效性研究的成果。该设备包括一个精准的远程控制机器，可以在实时成像过程中引导微导管通过腿部血管进入大脑。到达动脉瘤后，动脉的一侧已经膨胀成球状并且有破裂的风险，该装置可以将材料线圈送入血管中，以帮助阻止血流并减轻压力。新闻稿指出，这项前瞻性、单臂、国际性、多中心、非劣效性研究是世界上首个关于机器人辅助神经血管动脉瘤栓塞手术的试验。研究结果显示，CorPath GRX神经血管系统成功完成了94%的机器人辅助血管内手术，且外科医生在手术过程中无需切换到手动的方法。超过64%的患者的动脉瘤完全消失，78%的患者在手术后没有临床症状。该公司表示，其余22%的患者的神经残疾改良RANKIN量表（mRS）得分也仅有1或2分，这意味着他们能够独立照顾自己，并且可以继续进行大多数的日常活动。此外，CorPath GRX神经血管系统在95.7%的病例中达到了安全目标，即在手术或患者出院后24小时内未发生血管损伤、破裂或任何后续血液凝固事件。总结来说，CorPath GRX系统可帮助医生在曲折和不稳定的血管内有效地移动微导管。CorPath GRX此前已获得了FDA和欧洲的批准，可用于经皮冠状动脉介入治疗和其他心血管手术。此外，CorPath GRX还获得了脑部手术的CE认证。目前，该公司的目标是为CorPath GRX获得更多神经血管相关适应症的监管许可。Pixium Vision治疗萎缩性干性年龄相关性黄斑变性（干性AMD）的仿生视觉系统在意大利完成首位患者的植入近日，致力于开发创新的仿生视觉系统使失明的患者能够维持生活独立性的生物电子公司Pixium Vision宣布，在意大利开展的PRIMAvera关键试验中成功将其开发的仿生视觉系统Prima植入首位患者。该系统被用于治疗萎缩性干性年龄相关性黄斑变性（干性AMD）。该仿生视觉系统是Pixium Vision利用视觉处理、微电子学、光电学、神经生物学和智能软件算法的快速发展，加上其在脑机接口和人工智能（AI）方面的能力开发而成的，旨在补偿患有视网膜退行性疾病的患者的严重视力丧失，并改善这类患者生活的独立性、可动性和生活质量。研究人员表示，PRIMA尺寸小巧，并且是无线设计的。这意味着植入该系统的手术过程非常简单，也将为那些患有干性AMD的患者及其家属带来了巨大的希望。图片来源：Pixium Vision官网此次开展的PRIMAvera研究旨在确认Prima系统为患者提供的安全性和益处，也是该系统在欧洲寻求市场批准前最后的临床步骤。该研究于2020年第四季度在法国启动，此后在德国、英国和荷兰建立了更多的临床站点。ONWARD Medical无创脊髓刺激技术的大规模临床研究达积极终点ONWARD Medical是一家致力于创造创新疗法以恢复脊髓损伤（SCI）患者的运动、独立活动和健康的医疗技术公司。该公司于近日宣布，其开发的旨在恢复运动障碍患者的运动和其他功能的专有非侵入性脊髓刺激技术ARC-EX的关键研究Up-LIFT达到了改善患者上肢力量和功能的主要有效性终点。Up-LIFT研究是一项前瞻性、单臂研究，旨在评估ARC-EX疗法治疗慢性四肢瘫痪患者（全身瘫痪）的上肢功能缺陷的安全性和有效性。该研究在美国、欧洲和加拿大的14个主要的SCI中心招募了65例患者。这些患者的平均脊髓受伤时间为5.9年（范围为1至34年），平均受试者年龄为46.5岁。参与者在大约4个月的时间内平均完成了50次训练课程。在基线时和此后每月进行一系列综合评估以检测上肢的感觉和运动功能的变化。这些变化能直接转化为患者在日常生活中活动功能表现方面上的改善。研究结果显示，患者的上肢力量和功能具有统计学意义和临床意义上的改善。该公司计划在未来6个月内在美国和欧洲递交监管批准申请，目标是在2023年下半年推出ARC-EX疗法。更多科技相关资讯FDA授予CurveBeam AI开发的OssView骨脆性软件“突破性医疗器械认定”。OssView可以通过计算结构脆性评分（SFS）来评估骨微观结构的状态，从而帮助医疗服务提供者确定70岁以上女性的骨脆性和骨折风险。FDA授予Potrero Medical开发的用于深度预测急性肾损伤（AKI）相关的心脏手术后重症监护患者的腹内高压（IAH）机器学习算法“突破性医疗器械认定”。将该算法与Potrero Medical的重症监护系统Accuryn相结合，将进一步增强该系统的临床决策支持功能。临床级血液采集解决方案供应商Tasso宣布，其用于远程医疗测试的家用血液采集设备Tasso+ lancet获得了美国FDA的 510（k）认证。Tasso+ lancet可以由用户自己放在他们的上臂上进行操作，按下按钮即可从毛细血管抽出一小管血液。该方法可确保在家庭和医疗保健环境中安全有效地使用采血针。专注于提供个体化膝关节和髋关节置换产品的医疗技术公司Conformis宣布，其开发的Actera髋关节系统获得了美国FDA的 510（k）认证。药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息参考资料：[1] Pixium Vision announces implantation of first patient in Italy in Prima System European pivotal trial PRIMAvera. Retrieved September 13, 2022, from https://www.pixium-vision.com/2022/09/implantation-of-first-patient-in-italy-in-prima-system-european-pivotal-trial-primavera/[2] ONWARD Reports Positive Topline Results from a Pivotal Study to Restore Arm and Hand Function in People With Spinal Cord Injury. Retrieved September 13, 2022, from https://www.businesswire.com/news/home/20220912005943/en/ONWARD-Reports-Positive-Topline-Results-from-a-Pivotal-Study-to-Restore-Arm-and-Hand-Function-in-People-With-Spinal-Cord-Injury[3] Corindus, A Siemens Healthineers Company, Announces Study Results Demonstrating Safety and Effectiveness of CorPath GRX Neurovascular System®. Retrieved September 12, 2022, from https://www.corindus.com/news-events/press-releases/corindus-a-siemens-healthineers-company-announces-study-results-demonstrating-safety-and-effectiveness-of-corpath-grx-neurovascular-system[4] Siemens Healthineers' Corindus surgical robot clears brain aneurysm study. Retrieved September 12, 2022, from https://www.fiercebiotech.com/medtech/siemens-healthineers-corindus-surgical-robot-clears-brain-aneurysm-study[5] FDA Grants Breakthrough Device Designation for CurveBeam AI's OssView™ Bone Fragility Software. Retrieved September 12, 2022, from https://curvebeamai.com/news/fda-grants-breakthrough-device-designation-for-curvebeam-ais-ossview-bone-fragility-software/[6] Potrero Medical Receives FDA Breakthrough Device Designation for Accuryn AKI Predict Algorithm. Retrieved September 13, 2022, from https://potreromed.com/potrero-medical-receives-fda-breakthrough-device-designation-for-accuryn-aki-predict-algorithm/[7] Conformis Actera™ Hip System Receives 510(k) Clearance from the U.S. Food and Drug Administration. Retrieved September 13, 2022, from https://www.globenewswire.com/news-release/2022/09/13/2515498/0/en/Conformis-Actera-Hip-System-Receives-510-k-Clearance-from-the-U-S-Food-and-Drug-Administration.html[8] Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance. Retrieved September 14, 2022, from https://www.tassoinc.com/press-releases/tasso-device-earns-fda-510k-class-ii-medical-device-clearance免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

Sarah Silbiger/Getty Images The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week. September 16 Abiomed reported the FDA approved the on-label RECOVER IV trial in AMI cardiogenic shock patients. The agency also approved and closed Impella’s prospective AMI cardiogenic shock post-approval study, RECOVER III. September 15 Mallinckrodt announced the FDA approved Terlivaz (terlipressin) for injection to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Aro Biotherapeutics was granted Rare Pediatric Drug (RPD) designation for ABX1100 for the treatment of Pompe disease. Kymera Therapeutics’ KT-333 received Orphan Drug Designation for the treatment of cutaneous T-cell lymphoma (CTCL). 20/20 Imaging, a division of Konica Minolta Healthcare Americas received FDA clearance of the Chiropractic Straight Arm (CSA) system with Dynamic Digital Radiography (DDR). It allows for visualization of anatomy in motion. Inversago Pharma received clearance to launch a Phase II trial of INV-202, a a small molecule CB1 inverse agonist/antagonist, for diabetic kidney disease. Jasper Therapeutics’ JSP191 received Fast Track Designation for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant. The drug is an anti-CD117 monoclonal antibody. September 14 TRACON Pharmaceuticals received Fast Track Designation for envafolimab, a single-domain antibody against PD-L1 licensed by TRACON from Alphamab Oncology. The designation is for soft tissue sarcoma subtypes of locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma. Aldeyra Therapeutics reported it had received the official minutes from its pre-NDA meeting with the FDA. It is on schedule to submit the NDA in the fourth quarter for the novel RASP modulator reproxalap for dry eye disease. Revive Therapeutics submitted an amended Phase III COVID-19 trial protocol to the FDA to evaluate Bucillamine in mild to moderate COVID-19. Transcenta Holding Limited announced the FDA cleared its TST003, a first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, for a Phase I trial. Tasso’s Tasso+ lancet was cleared by the FDA as a Class II medical device. This allows Tasso to market and sell to more customers across the U.S. September 13 Marker Therapeutics received a $2 million grant from the FDA Orphan Products Grants program in support of its Phase II ARTEMIS trial of MT-401 in patients with post-transplant acute myeloid leukemia. SetPoint Medical stated the FDA approved continuation of its RESET-RA trial, which received an Investigational Device Exemption (IDE) to evaluate patients with rheumatoid arthritis in January 2021. Otsuka and H. Lundbeck A/S announced the FDA accepted their New Drug Application for aripiprazole for the treatment of schizophrenia in adults and for maintenance monotherapy of bipolar I disorder in adults. Akouos received clearance to initiate a Phase I/II pediatric clinical trial of its gene therapy AK-OTOF for otoferlin gene-mediated hearing loss. Potrero Medical reported the FDA granted Breakthrough Device Designation for its AKI Predict machine learning algorithm for the purpose of predicting acute kidney injury associated with intra-abdominal hypertension in cardiac post-surgical intensive care patients. aTyr Pharma's efzofitimod received Fast Track Designation for the treatment of systemic sclerosis (SSc)-associated interstitial lung disease. September 12 BioLineRx submitted an NDA to the FDA for motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients. Ocuphire Pharma was granted a small business waiver of the $3.1 million PDUFA fee for the 505(b)(2) NDA for Nyxol (phentolamine ophthalmic solution). CurveBeam AI announced its medical diagnostic software, OssView, received Breakthrough Device Designation. OssView calculates a Structural Fragility Score (SFS), which determines the deterioration of bone microstructures. Acadia Pharmaceuticals’ NDA for trofinetide for Rett syndrome was granted priority review and assigned a PDUFA date of March 12, 2023. Mersana Therapeutics received Fast Track Designation for XMT-1660 to treat triple-negative breast cancer.