Cresilon Receives FDA Clearance for TRAUMAGEL: A New Algae-Based Gel Treats Severe Bleeding in Seconds Cresilon Inc's Traumagel has been cleared by the FDA as an emergency treatment to control moderate to severe bleeding. The product uses a proprietary algae-derived hydrogel technology developed by the Brooklyn-based company. This is the second gel-based treatment successfully pushed through by Cresilon, following the FDA’s clearance of its Hemostatic Gel in June 2023. While that gel was cleared to patch up small nicks and cuts, Traumagel is intended to mend bleeding from much more serious injuries like gunshot wounds, stabbings, and car crashes. The FDA cleared Traumagel based on preclinical data showing that it performed similarly to standard wound care treatments in use today. However, the company argues that their product has several advantages over existing interventions, such as taking only seconds to start working. The gel is also purportedly easy to deploy, with a pre-filled syringe that requires no added pressure on the wound, and can be used to treat all types of bleeding. Severe blood loss can kill in a matter of minutes, whether from a gunshot wound or a massive injury-related hemorrhage. A person dies from injury nearly every 3 minutes, and 40% of these deaths are due to major hemorrhage or its consequences. Death from hemorrhage is early, with up to 60% of deaths occurring within the first 3 hours of injury. “The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic wounds,” said Cresilon CEO, co-founder, and inventor Joe Landolina in a statement from the company. “The FDA clearance for Traumagel is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and transform the standard of care in wound treatment. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.” The company expects to start launching the gel in late 2024 and will market its product to the U.S. military, government health agencies, emergency medical services systems, and other medical professionals who regularly treat trauma patients. The company is also researching and developing a new product in conjunction with the U.S. Defense Department as a potential field and prehospital treatment to help manage life-threatening brain hemorrhages and traumatic brain injuries. According to the company, early results have been promising. Scientists elsewhere have been working on their own gel-based technologies intended to improve medical care. Researchers have developed bandages infused with gel to speed up healing, for instance, while others are using gels as a form of male birth control or help treat conditions like Parkinson’s disease or back pain. https://lnkd.in/ei48PQFK
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Cresilon Receives FDA Clearance for #TRAUMAGEL NEW YORK August 15, 2024 Hemostatic gel designed to control moderate to severe bleeding in seconds and save lives Cresilon Inc., a Brooklyn-based biotechnology company focused on #hemostatic #medicaldevice technologies, today announced it has received U.S. FDA #510k clearance for TRAUMAGEL® for temporary external use for controlling moderate to severe #bleeding. Cresilon’s revolutionary plant-based hemostatic gel technology is designed to stop and control life-threatening bleeding in a matter of seconds when applied to a wound at the point of care. TRAUMAGEL, which utilizes Cresilon’s proprietary hydrogel technology, is a first-of-its-kind hemostatic medical device with FDA clearance for temporary external use in moderate to severe bleeding. Cresilon intends to develop and manufacture TRAUMAGEL to address the needs of the U.S. military, government health agencies, emergency medical services (“EMS”) systems, and medical professionals who routinely encounter traumatic wounds and need a solution to quickly and effectively stop and control severe bleeding. The company plans to initiate a strategic launch of TRAUMAGEL in the U.S. late 2024. “The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,”said Joe Landolina. “The FDA clearance for TRAUMAGEL is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and transform the standard of care in emergency medicine. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.” Severe blood loss can kill in a matter of minutes, whether from a gunshot wound or a massive injury-related hemorrhage. A person dies from injury nearly every 3 minutes, and 40% of these deaths are due to major hemorrhage or its consequences. Death from #hemorrhage is early, with up to 60% of deaths occurring within the first 3 hours of injury. While several hemostatic agents and gauze bandages are currently available for applications such as trauma and surgery, many products require preparation and lengthy application time, can be difficult to apply, or are not suited to work across all types of bleeds. ➡️𝐂𝐫𝐞𝐬𝐢𝐥𝐨𝐧’𝐬 #𝐩𝐥𝐚𝐧𝐭𝐛𝐚𝐬𝐞𝐝 𝐡𝐞𝐦𝐨𝐬𝐭𝐚𝐭𝐢𝐜 𝐠𝐞𝐥 𝐢𝐬 𝐬𝐮𝐩𝐩𝐥𝐢𝐞𝐝 𝐢𝐧 𝐚 𝐩𝐫𝐞-𝐟𝐢𝐥𝐥𝐞𝐝 𝐬𝐲𝐫𝐢𝐧𝐠𝐞, easy-to-apply, requires no preparation, and designed to stop bleeding quickly across all types of bleeds.⬅️ #PersonalCuriosity: it would have been interesting to have more details on the mechanism of action of this MD, to understand if such a product, considering the magnificent and very clear #MDCG 2022-5 (🤪a #lighthouse in the fog when it comes to plant-based MDs🤪), would then be classifiable as a medical device also in #Europe. European Commission Corte di giustizia dell’Unione europea
Cresilon Receives FDA Clearance for TRAUMAGEL - Cresilon
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Sharing this paper I would like to emphasize the importance of Patient Blood Management (PBM) in anesthesia. Keeping the focus on conserving patients' own blood and using transfusions judiciously to improve outcomes and reduce healthcare costs. Recent evidence supports a restrictive approach to red blood cell transfusions, aligning with the principles of PBM. While ongoing research is needed to further validate PBM interventions, the translation of guidelines into practical recommendations is key to making PBM the standard of care in anesthesia. Let's work together to enhance patient safety and optimize healthcare efficiency through PBM implementation. #PatientBloodManagement #Anesthesia #HealthcareEfficiency #coagulation #transfusion https://lnkd.in/dPGMPh3r
Patient blood management as the standard of care
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📃Scientific paper: Double J stent combined with pyelostomy tube in pediatric laparoscopic pyeloplasty: a 5-year clinical experience in a single center Abstract: Objective To compare the outcome of using a double J (DJ) stent combined with pyelostomy tube with a DJ stent alone in laparoscopic pyeloplasty (LP) for pediatric ureteropelvic junction obstruction (UPJO). Methods A retrospective review of all patients with UPJO treated with LP between January 2017 and November 2021 was conducted in our center. According to different postoperative drainage methods patients were divided into a DJ stent group (52 cases) and a DJ stent combined with pyelostomy tube group (combination group, 41 cases). Operative time, bleeding volume, perirenal drainage stent removal time, postoperative hospital stay, postoperative complications, and renal function recovery were compared between the two groups. Renal ultrasound and diuretic renogram (DR) were used for preoperative and postoperative follow-up. Results A total of 52 patients were in the DJ stent group and 41 patients in the combination group. The mean hospital stay was 6.46 ± 2.66 days in the DJ stent group and 5.22 ± 1.63 days in the combination group (p < 0.05). Postoperative complications developed in 14 out of 52 patients in the DJ stent group (26.9%), while complications developed in 8 out of 41 patients in the combination group (19.5%) (p > 0.05). Non-catheter-related complications developed in 10/52 patients in the DJ stent group (19.2%) and only 1/41 patients in the combination group (2.4%) (p < 0.05). The renal function and renal cortex thickness in both groups were improved. C... Continued on ES/IODE ➡️ https://etcse.fr/ChE ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.
Double J stent combined with pyelostomy tube in pediatric laparoscopic pyeloplasty: a 5-year clinical experience in a single center
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Welcome to another Medical Monday! Doctors offering wound care for diabetic patients face several industry issues that can impact the effectiveness and efficiency of treatment unless they are using a model that helps address those hurdles. We asked ChatGPT to give us the top concerns – we’ll cover 4 challenges / solves this week, and finish next week. This week, the challenges include: Rising Incidence of Diabetes: The US increase in diabetes prevalence was straining current healthcare systems, making it difficult to provide timely and adequate care for all patients needing wound care. Diabetic wounds require early and aggressive treatment to prevent complications. This is why we provide a program with assessment software to begin advanced care with biologics as early as possible under CMS guidelines. This is also why CMS opened the field of treatment up to part B billers, like primary care, family practice, podiatry and dermatology – the rate of increase was so dramatic that previous channels couldn’t handle the volume. Cost and Reimbursement Issues: The cost of advanced wound care products and treatments can be high, and reimbursement rates may not fully cover these expenses. This is why we developed very thorough ordering, documenting and billing software and procedures for the doctors we work with. If there is any gap, we want everyone to know – and we work to make sure that gap is covered and that each order and treatment submission clear, are paid and avoid denials and claw backs. Access to Specialized Care: There's a shortage of specialists trained in wound care and diabetic foot management. Many patients live in areas where access to specialized care is limited, delaying diagnosis and treatment of diabetic wounds, which can lead to worsened outcomes. This is one of the main issues our model helps address – making wound care much more universally available, accessible and immediate, no matter where the patients are located geographically. Depending on the state, there are a wide variety of practitioners who are now allowed to participate in their patients wound care treatments. Patient Compliance: Managing diabetic wounds requires significant patient involvement, including regular dressing changes, monitoring for signs of infection, and lifestyle adjustments to promote healing. Patient noncompliance with traditional treatment plans is a common issue. This used to be much more prevalent as a concern when we were speaking about wet-wraps, dry-wraps, wound vacs, and Manuka honey as treatments – the chance for both infections and recurrence was much higher – and the healing time was much longer. Now, with the modalities we support, healing in measured in weeks-months, and infection and recurrence rates are also dramatically reduced. We see results that are far better than in times that are far faster than ever before.
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❤️October is vEDS Action Month. vEDS Awareness saves lives. vEDS can cause life-threatening complications, such as aneurysm, dissection, and rupture of the arteries and rupture of organs, mainly the bowel. All medical professionals involved in a person’s care should be aware of their vEDS diagnosis and the risks associated with it. 🏥vEDS can affect all areas of medical care. It’s important to consider tissue fragility & potential for sudden, severe, & life-threatening complications during any interventions. Conservative approaches should be considered when possible. Elective procedures should be avoided due to the higher surgical risks associated with vEDS. 🚑Emergency providers must be made aware that a person has vEDS in order to provide appropriate care. People with vEDS are encouraged to carry emergency information with them to help them get the right emergency care. People with vEDS require tailored medical care, and conservative management options should be considered before surgery due to the higher surgical risks associated with vEDS. 💊High blood pressure puts stress on the blood vessel walls, which are very fragile in vEDS. Medications are often used to keep blood pressure at a normal or low level and prevent large changes in blood pressure. Beta-blockers and angiotensin II receptor blockers (ARBs) have been shown to improve clinical outcomes for those with vEDS when combined with specialist care and advice. Most people with vEDS should have regular vascular imaging to screen for potential complications. This helps them be addressed in a planned procedure rather than an emergency. It’s important to investigate suspected vascular events— symptoms can be subtle. Find information and support groups and resources on vEDS at: https://lnkd.in/eZd7hDC2
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⚠️ECPR⚠️ 🟡Extracorporeal cardiopulmonary resuscitation (ECPR) is a salvage procedure in which extracorporeal membrane oxygenation (ECMO) is initiated emergently on patients who have had cardiac arrest (CA) and on whom the conventional cardiopulmonary resuscitation (CCPR) has failed. 🟡The aim of ECPR is to provide adequate perfusion to the end-organs when the potentially “reversible” conditions were managed. 🟡ECPR is an emergency procedure. Well-defined criteria to help in selection of ideal patients for ECPR are mandatory to save the deserving CA patients and to differentiate from the patients on whom the ECPR’s outcome is unacceptably low. Unfortunately, there is no uniform consensus on those criteria. Selection criteria accepted by most of the centres are: Inclusion criteria 🟨Witnessed CA of cardiac origin or without any obvious cause. 🟨No sustained ROSC for the first 10 min (for a few centres, it is 20 min) of conventional CPR CPR duration less than 10 min. 🟨Ventricular fibrillation (VF), pulseless ventricular (pVT)on initial ECG. Exclusion criteria 🟨Known severe irreversible brain damage. 🟨Terminal malignancy. 🟨Traumatic origin with uncontrollable bleeding. 🟨Acute aortic dissection. 🟨Non-cardiac origin (asphyxia, submersion, primary cerebral disorder). 🟨Irreversible organ failure (like liver failure and late-stage advanced adult respiratory distress syndrome). 🟨Severe sepsis. 🟨Poor level of activities of daily living before CA. ECPR in children: 🟡Most of the ECPR managements are similar in paediatric and adult population. 🟡ECPR in the postoperative period following corrective or palliative surgery for congenital heart disease (CHD) is the most common indication for ECPR in the paediatric age group. This condition has better prognosis than other conditions. 🟡Cardiac arrhythmias, tamponade, pulmonary hypertension, hypoxemia due to pulmonary blood flow obstruction, myocardial dysfunction and residual lesions are the frequent causes for cardiac arrest in the postoperative period following surgery for CHD. Technique and Application: 🟡The mode of support for ECPR is VA since other modes (venovenous, arteriovenous) provide gas exchange but not circulatory support, whereas VA support provides both. 🟡VA support involves cannulation of the right atrium for venous drainage and the aorta or a large artery (femoral or carotid) for return to the arterial system. 🟡The heart and lungs are bypassed during ECPR, and the extracorporeal circuit provides full cardiopulmonary support. 🟡On ROSC, systemic blood flow is the sum of native cardiac output and extracorporeal flow. Complications: 🟡Bleeding is the most common complication associated with all forms of ECLS, including ECPR. The most common site of bleeding is cannulation site. #cardiology #perfusion #perfusionist #cardiacsurgery #cardiovascular #cpr #ecpr #health #medical
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DO NOT MISS - LIVE Webinar - 6 HOURS of Education : Elevating Patient Care: Harnessing the Synergistic Effects of Ozone and Vitamin C Therapies In the ever-evolving landscape of medical practice, the pursuit of optimal patient care often leads us to explore innovative and complementary treatment modalities. Today, I wish to shed light on the synergistic relationship between ozone therapy (OT) and vitamin C therapy, underscoring how their combined use can elevate clinical outcomes, particularly in patients with chronic diseases. Ozone Therapies: Ozone therapy offers a versatile array of administration routes, including intravenous, intra-articular, and rectal insufflation, tailored to specific clinical needs and patient conditions. Renowned practitioners like Dr. Frank Shallenberger, Dr. Robert Rowen, and Dr. Howard Robins have refined various ozone therapy applications and routinely combine it with Sodium Ascorbate Vitamin C to enhance clinical outcomes. Beyond its direct intravenous gas (DIV) application, ozone is frequently injected into body cavities, soft tissues, and joints—a practice known as Prolozone or Prolozone therapy. This therapy demonstrates exceptional safety, with minimal risks when performed properly. Ozone's profound impact on oxygen metabolism and its redox properties confer virucidal and bactericidal effects, making it valuable in combating infections and enhancing tissue repair. In dentistry, ozone finds extensive application across a spectrum of pathologies, including infection management, biofilm treatment, and wound healing acceleration. Its safety extends even to later pregnancy, where it may offer benefits for placental function. Vitamin C Therapies: Vitamin C, often regarded as a sister oxidative therapy to ozone therapy (OT), offers a complementary approach to enhancing various OT applications. High-dose intravenous vitamin C showcases a striking parallel in its mechanisms of action to OT, amplifying ....Read More Below: practice.https://https://lnkd.in/eTXYpVgf
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Surgical PracticeEarly View CASE REPORT Streptococcus constellatus appendicitis in children: A case series Abstract Background Streptococcus constellatus (SC) is a pathogen well-known for its involvement in pyogenic infections, with a notable preference for manifesting within the oral cavity, head and neck, and abdomen. This bacterium, belonging to the Streptococcus milleri group, has garnered attention for its propensity to incite inflammatory processes, especially in the abdominal region. Objectives This study aims to present and characterise nine cases of paediatric patients with SC appendicitis. Methods We conducted a report on nine cases of SC appendicitis, all of whom presented to the emergency room with typical symptoms of appendicitis. Results Patients diagnosed with SC appendicitis exhibited a severe clinical course, necessitating appendectomy at presentation and requiring prolonged parenteral antimicrobial therapy. Furthermore, a higher readmission rate was observed among these patients, even several months after their initial discharge. Conclusions Surgeons should be vigilant regarding SC appendicitis and its severe clinical course. Prolonged treatment with antimicrobial agents may be necessary for these patients to achieve better outcomes.
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Majority of various risk factors for gastric ulceration may not predict gastric mucosa lesion in ICU patients receiving standard pharmacological prophylaxis undergoing endoscopy for PEG implantation. We found that history of gastric ulcer may be a risk factor for gastric ulceration in the ICU patients. Patients with history of gastric ulcer might benefit from higher than standard doses of anti-ulcer medication when hospitalized in the ICU. Take a look at our article in BMC Gastroenterology! https://lnkd.in/dRRF9Xp5
Risk factors for gastric mucosa lesion in critically ill patients undergoing endoscopy for percutaneous gastrostomy: a case-control study - BMC Gastroenterology
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Suspected UTI: How Urinary Tract Infections Can Lead To Kidney Issues When Misdiagnosed Or Inadequately Treated. People expect to receive the best care possible when visiting a doctor, urgent care, or hospital. However, while medical professionals undergo extensive training, especially when it comes to surgery and treatment, even doctors and nurses can make very serious mistakes that can result in injuries to a patient. One potentially serious injury is kidney issues, which can have devastating consequences. Read more at https://lnkd.in/gQNuB8DV
Suspected UTI: How Urinary Tract Infections Can Lead To Kidney Issues When Misdiagnosed Or Inadequately Treated
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