INTERCEPT® Blood System USA’s Post

Join Cerus at the Society for the Advancement of Patient Blood Management, Inc. (SABM) 2024 Annual Meeting at the Hyatt Regency Phoenix in Phoenix, AZ, September 12–14, 2024! Be sure to attend Cerus’ Industry Workshop, “Protecting the Blood Supply with Pathogen Reduction: Current and Future Perspectives”, on September 12 at 3:00 p.m. The workshop features Nina Mufti, PhD discussing recent findings on the ReCePI trial, a Phase III trial evaluating the use of pathogen reduced red cell components in cardiovascular surgery patients¹ and Andrea McGonigle M.D. presenting on UCLA’s experience with Pathogen Reduced Cryoprecipitated Fibrinogen Complex, commonly referred to as INTERCEPT® Fibrinogen Complex (IFC), in postpartum hemorrhage. Register here: https://ow.ly/ksJ150SV6BN Please visit us at Booth #17 in the Exhibition Hall to learn more! Find out why hospitals are using INTERCEPT treated blood components: https://ow.ly/y2Pq50SV6BM #INTERCEPT #pathogeninactivation #JOINTHEMOVEMENT #IFC #bloodsafety #patientbloodmanagement 1. The INTERCEPT Red Blood Cell system is in clinical development. (ClinicalTrials.gov ID NCT03459287). INTERCEPT Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex: INDICATIONS FOR USE •Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. • Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available. • Second-line therapy for von Willebrand disease (vWD). • Control of uremic bleeding after other treatment modalities have failed. Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII. CONTRAINDICATIONS Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex. For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered. ©2024 Cerus Corporation. Cerus, INTERCEPT, and the Cerus logo are registered trademarks of Cerus Corporation. MKT-EN 00685-55 v1.0

‼️📢‼️FDA MEDWATCH - FDA SAFETY COMMUNICATION on BioZorb Markers and Potential Risks with Use in Breast Tissue‼️📢‼️ The FDA issued a safety communication to inform patients and health care providers about the potential risk of serious complications with the use of Hologic BioZorb Marker and BioZorb LP Marker devices in breast tissue. To read more and find out about what the safety communication provides, follow the link below. #fda #safety #breastimaging #biomarkers #softtissue #radiography #hologic #cosmeticsindustry #cosmeticscience #radiation #radiationtherapy #radiationoncology #breastcancerawareness #breastcancer #breastcancercare #healthcareindustry #risks #serious #complications #medicaldeviceregulation

The Use of Hyperbaric Oxygen Therapy to Manage Complications Associated with Nipple-Sparing Mastectomy and Breast Reconstruction: An Overview Summary: The existing literature indicates that Hyperbaric oxygen therapy has the potential to mitigate various postoperative complications associated with nipple-sparing mastectomy, including ischemia and necrosis/ flap loss, infections, seroma, and hematoma. By improving tissue oxygenation and vascularization, HBOT can effectively reduce inflammation, stimulate angiogenesis, and promote cellular repair, ultimately leading to better outcomes for patients. Notably, a substantial proportion of patients did not require additional surgical interventions, indicating HBOT’s potential to limit the need for further surgeries by effectively managing threatened skin flap necrosis in the postoperative period. Although early initiation of hyperbaric oxygen therapy (HBOT) within the optimal 2-day post-operative period is ideal, patients can benefit from HBOT even if treatment is delayed beyond this timeframe. The evidence indicates that HBOT does not appear to stimulate tumour metastasis or more aggressive growth, suggesting its oncological safety. While the existing evidence suggests that hyperbaric oxygen therapy holds promise in managing postoperative complications associated with nipple-sparing mastectomy, further rigorous clinical research with well-designed control groups is necessary to establish standardised HBOT protocols that optimise its effectiveness in this context. HBOT is generally safe and well-tolerated when administered correctly, but there are rare side effects, and it may not be suitable for every oncology patient. Therefore, patients need careful assessment by a physician with expertise in hyperbaric oxygen medicine before considering this therapy as an adjunctive treatment option. Full article - https://lnkd.in/eeb_-izV #️⃣ hyperbaricoxygen #️⃣ HBOT #️⃣ Hyperbaricoxygentherapy #️⃣ NippleSparing Mastectomy #️⃣ BreastReconstruction

‼️📢‼️FDA MEDWATCH - FDA SAFETY COMMUNICATION on BioZorb Markers and Potential Risks with Use in Breast Tissue‼️📢‼️ The FDA issued a safety communication to inform patients and health care providers about the potential risk of serious complications with the use of Hologic BioZorb Marker and BioZorb LP Marker devices in breast tissue. The BioZorb Marker and BioZorb LP Marker are devices implanted in soft tissue, including breast tissue, to mark the site for future medical procedures, such as radiation for breast cancer treatment. The FDA has received reports and is aware of published literature describing serious adverse events in patients who were implanted with the BioZorb Marker or BioZorb LP Marker devices in the breast tissue. The FDA has cleared BioZorb Marker and BioZorb LP Marker for radiographic marking of sites in soft tissue (including breast). Also, the markers are indicated in situations where the soft tissue site (including breast) needs to be marked for future medical procedures. The FDA has not cleared or approved these devices to fill space in the tissue or to improve cosmetic outcomes after procedures. To read more and find out about what the safety communication provides, follow the link below. #fda #safety #breastimaging #biomarkers #softtissue #radiography #hologic #cosmeticsindustry #cosmeticscience #radiation #radiationtherapy #radiationoncology #breastcancerawareness #breastcancer #breastcancercare #healthcareindustry #risks #serious #complications #medicaldeviceregulation

Happy to share findings from this sub-analysis of the DISCHARGE trial recently published by Radiology. We are proud to be part of this fantastic trial lead by Marc Dewey, MD The study encompassed 3457 participants, revealing no significant difference in major adverse cardiovascular events (MACE) between patients managed initially with CT and those with ICA, across all BMI subgroups. Interestingly, the CT group showed a lower incidence of expanded MACE composite events and major procedure-related complications, highlighting its potential as a less invasive management strategy. However, a higher nondiagnostic CT rate was observed in participants with a BMI exceeding 30 kg/m², indicating the need for careful consideration in this subgroup. These findings support the use of cardiac CT as an effective and possibly safer initial diagnostic approach in patients with stable chest pain, regardless of BMI. This could pave the way for more personalized and less invasive management strategies in coronary artery disease ultimately improving patient outcomes. #CardiacImaging #DISCHARGEtrial #Cardiology #Research #HealthcareInnovation https://lnkd.in/dKPir7Y9

Cardiac sarcoid behaves different than LN sarcoid... interesting case 42 year old gentlemen suspected to have sarcoidosis underwent PET CT 🛎️Image column 1- Initial Evaluation: Assessment: PET scan reveals active disease in mediastinal lymph nodes (LN) and heterogeneous positive uptake in cardiac tissue. Complications and Treatment Initiation: Patient experiences cardiac related issues.Initiated on steroid therapy and considered for an Implantable Cardioverter-Defibrillator (ICD). 🛎️Image column 2- Follow-Up PET Scan- 3 Months Post-Therapy: Response: Partial response to therapy; residual uptake noted. 🛎️Image column 3- 6 Months Post-Therapy: Response: Complete metabolic response (CMR) achieved. Steroid Tapering was considered : 3 Months Post-Tapering: experiences ICD activation. 🛎️Image column 4 PET CT Scan: Reveals recurrence of cardiac disease and inactive mediastinal LN. Revised Treatment Plan: New Therapy: Initiated on methotrexate and continued steroid therapy. 🛎️Image column 5- Final PET Scan: Reveals complete metabolic response (CMR). 🏆5-Point Summary on PET in Cardiac Sarcoidosis: 🏹1.Diagnosis and Initial Assessment: PET scan is important for detecting active disease and evaluating the extent of disease involvement in sarcoidosis. 🏹2.Treatment Monitoring: PET scans help in assessing the response to therapy by identifying changes in disease activity and metabolic response over time. 🏹3.Complications Management: PET scans can reveal residual or recurrent disease, guiding adjustments in treatment strategies, such as steroid tapering or additional medications. 🏹4.Evaluation of Therapy Effectiveness: Serial PET scans provide valuable feedback on how well the therapy is working, CT helps in lung and liver drug toxicity assessment. 🏹5.Guiding Further Intervention: PET findings can impact decisions on interventions like ICD placement or changes in medication, ensuring a tailored approach to managing cardiac sarcoidosis.

"Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure physicians use to examine the pancreatic or bile ducts utilizing a combination of endoscopy and fluoroscopy to capture X-ray images of the ducts. Unfortunately, this procedure is not without risks. After undergoing ERCP, patients are typically observed for one hour before discharge. Post-ERCP pancreatitis, the most common adverse complication, can occur after discharge. Thiruvengadam Muniraj, MD, FACG, FRCP, associate professor of medicine (digestive diseases), Yale School of Medicine, and director, Center for Advanced Endoscopy at Yale New Haven Hospital, and his colleagues employ various techniques to mitigate this risk, such as using rectal non-steroid anti-inflammatory drugs (NSAIDs), placing pancreatic duct stents, and administering aggressive fluids. Despite the adoption of several such preventive strategies, the incidence of pancreatic inflammation after an ERCP remains substantial. On average, the incidence rate is 5-10%. For patients classified as high-risk, the likelihood increases to 25%, and the condition can be severe in rare cases. Identifying patients likely to develop pancreatitis post-ERCP is essential because they can benefit from overnight observation rather than being discharged. A newly published Yale-led study, “Clinical Predictive Value of Renalase in Post-ERCP Pancreatitis,” aims to assess whether a patient's renalase level influences the development of pancreatitis following an ERCP procedure." https://lnkd.in/eR3crBfs

Ophthopedia Update:Heterogeneity in disease activity, frequency of treatments, and visual outcomes among patients with retinal vein occlusion: relationship between injection need and vision with as-needed ranibizumab: Background/aims We characterised the relationships between monitoring frequency, ranibizumab injection need and vision in patients receiving as-needed (pro re nata; PRN) ranibizumab for macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in this post-hoc analysis of SHORE and HORIZON.Methods Patients aged 18 years and older with macular oedema due to BRVO/CRVO were included in this analysis. Injection frequency and best-corrected visual acuity (BCVA) were evaluated by PRN injection frequency in the PRN dosing phase (months (M) 7–15) of SHORE and through 12 months of HORIZON. Prespecified PRN re-treatment criteria for each trial were based on protocol-prespecified BCVA and optical coherence tomography outcomes.Results After the initial 7 monthly ranibizumab injections, patients in SHORE gained a mean of 18.3 letters from baseline. Patients randomised to PRN, on average, maintained these gains. However, some patients experienced additional mean gains, whereas others suffered losses (range 4.0 (95% CI 0.7 to 7.3) to –4.6 (95% CI –11.8 to 2.6) letters in patients who received 0 and 6–7 PRN injections, respectively). In BRAVO and CRUISE (lead-in trials), patients experienced mean gains from baseline to M6 (monthly dosing) of 19.3 and 15.0 letters, respectively, with gains maintained with PRN from M6 to M12. However, mean BCVA changes from baseline to M12 varied in HORIZON (range –0.4 (95% CI –2.5 to 1.6) to –3.6 (95% CI –6.2 to –1.0) letters in patients who received zero and six injections, respectively, during the preceding PRN phase of BRAVO and CRUISE).Conclusion The BRVO/CRVO population is heterogenous with a varied response to ranibizumab treatment. #Ophthalmology #Ophthotwitter #BJO

Ophthopedia Update:Heterogeneity in disease activity, frequency of treatments, and visual outcomes among patients with retinal vein occlusion: relationship between injection need and vision with as-needed ranibizumab: Background/aims We characterised the relationships between monitoring frequency, ranibizumab injection need and vision in patients receiving as-needed (pro re nata; PRN) ranibizumab for macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in this post-hoc analysis of SHORE and HORIZON. Methods Patients aged 18 years and older with macular oedema due to BRVO/CRVO were included in this analysis. Injection frequency and best-corrected visual acuity (BCVA) were evaluated by PRN injection frequency in the PRN dosing phase (months (M) 7–15) of SHORE and through 12 months of HORIZON. Prespecified PRN re-treatment criteria for each trial were based on protocol-prespecified BCVA and optical coherence tomography outcomes. Results After the initial 7 monthly ranibizumab injections, patients in SHORE gained a mean of 18.3 letters from baseline. Patients randomised to PRN, on average, maintained these gains. However, some patients experienced additional mean gains, whereas others suffered losses (range 4.0 (95% CI 0.7 to 7.3) to –4.6 (95% CI –11.8 to 2.6) letters in patients who received 0 and 6–7 PRN injections, respectively). In BRAVO and CRUISE (lead-in trials), patients experienced mean gains from baseline to M6 (monthly dosing) of 19.3 and 15.0 letters, respectively, with gains maintained with PRN from M6 to M12. However, mean BCVA changes from baseline to M12 varied in HORIZON (range –0.4 (95% CI –2.5 to 1.6) to –3.6 (95% CI –6.2 to –1.0) letters in patients who received zero and six injections, respectively, during the preceding PRN phase of BRAVO and CRUISE). Conclusion The BRVO/CRVO population is heterogenous with a varied response to ranibizumab treatment. #Ophthalmology #Ophthotwitter #BJO

Second Prospective Randomized Control Trial Demonstrating the Benefit of Peripheral IVUS! 237 patients with fempop disease randomized to IVUS-guided DCB treatment vs angio-guided DCB treatment. 14% improvement in patency at 1 year. Summary of results here: https://lnkd.in/gU-3Vggz This aligns with the 17% patency improvement seen in the Allan et al 150 person fem-pop RCT trail published in 2022: (https://lnkd.in/gRtz-rQr). Time is now to change your peripheral practice!! Learn more about peripheral IVUS here: https://lnkd.in/g-m7EpWg Society for Vascular Medicine Society for Cardiovascular Angiography & Interventions Society of Interventional Radiology VIVA Physicians