Medtrade Products Ltd announces CE certification for a ground-breaking solution for the management of postpartum haemorrhage

Medtrade Products Ltd is pleased to announce CE certification for its CELOX™ PPH Uterine Haemostatic Tamponade, a significant and  state-of-the-art innovation that provides rapid and effective control of postpartum bleeding, a prevalent and severe complication of childbirth. Gaining accreditation for this game-changing device is a significant medical milestone in the field of obstetrics.

Postpartum haemorrhage (PPH) is a leading cause of maternal mortality worldwide,¹ affecting approximately 14 million women and resulting in 80,000 deaths² each year. The International Federation of Gynaecology and Obstetrics (FIGO) has addressed the severity of this complication, recommending that all attempts should be made to reduce PPH using cost-effective, resource-appropriate interventions.³ With this in mind, CELOX PPH provides a unique proprietary technology that works independently of the patients own clotting mechanism, allowing rapid haemostasis and reduction in blood loss.  This innovation can be easily and rapidly deployed without the need for power, suction, saline or specific storage conditions associated with existing devices.

CELOX PPH provides rapid and effective control of PPH, demonstrating 100 % haemostasis for grade 1 and 2 bleeding (up to 2,500 ml)⁴ in all deliveries, and 95.6 % haemostasis for up to grade 3 bleeding (8,000 ml)⁴ in vaginal deliveries. The innovative product has also demonstrated a 78 % reduction in hysterectomy rate compared to the current standard of care, highlighting significant clinical benefits for patients who suffer with postpartum bleeding. Numerous peer reviewed publications have documented its efficacy in leading OBGYN journals over the last 10 years. The CE certification represents an exciting milestone for Medtrade Products Ltd, as well as for mothers and clinicians who will benefit significantly from this highly effective innovation to control and treat PPH.

The Department of Obstetrics at the Charité University Hospital in Berlin carried out an extensive clinical evaluation of the uterine tamponade and concluded that CELOX PPH is highly effective in the control and treatment of uterine PPH, consistently achieving haemostasis and avoiding further surgical therapy.^5,6,7 Prof Dr Wolfgang Henrich, Obstetric Medical Director at the Charité University Hospital, commented on the global potential of the technology: “CELOX PPH is a game changer in the management of PPH, due to its ease and speed of application, and high level of clinical efficacy. The device has the potential to help prevent postpartum blood transfusions, preserve fertility and conserve both medical and human resources.”

Russ Mably, the Chief Executive Officer at Medtrade Products Ltd, added: “CE approval is a major step forward in tackling the ongoing global challenge of PPH, and we are proud to be at the forefront of this medical development Our ambition is to make CELOX PPH available at every delivery across the world, to help address the unacceptable rates of maternal mortality caused by PPH.”

 

For more information, please visit www.celoxpph.com or contact us at info@celoxpph.com.

 

About Medtrade

Established in 1999, Medtrade is a UK-based biotechnology company developing and launching industry-leading solutions to partners across the world. With offices in Crewe, UK and New York, US, the highly experienced leadership and specialist teams are committed to supporting business partners and healthcare practitioners with market-leading solutions across women’s health, wound care, trauma and haemostasis sectors. Medtrade manages the entire product development process through to full product commercialisation. Integral to the success of Medtrade is the continued focus on innovation and a dedicated team is in place. New innovations aimed at addressing key global healthcare challenges such as biofilms, wound treatment, infection prevention, pressure injury prevention and control of bleeding are very much the focus. ISO 13485 certified, we have a successful legacy of providing market-leading solutions to brand owners and our success is built upon an enviable track record of quickly and efficiently supporting brand owners with key or flagship products in support of their strategic marketing objectives.

 

 

Enquiries:

Medtrade Products Limited

Tel: +44 (0)1270 500019

Email: info@celoxpph.com

• andy.sutcliffe@medtrade.co.uk – Andy Sutcliffe, Global Strategic Marketing Director

 

* See IFU instructions for use for intended use, contraindications, warnings and precautions: available at www.celoxpph.com

 

References:

1. World Health Organisation. (2005). Make every mother and child count. The World Health Report. ISBN: 9241562900.
2. Borovac-Pinheiro, A., Pacagnella, R. C., Cecatti, J. G., et al. (2018). Postpartum hemorrhage: new insights for definition and diagnosis. Am J Obstet Gynecol. 219(2), 162–168. doi: 10.1016/j.ajog.2018.04.013z
3. Escobar, M. F., et al. (2022). FIGO recommendations on the management of postpartum hemorrhage 2022. International Journal of Gynecology & Obstetrics. 157(S1), 3-50. doi: https://doi.org/10.1002/ijgo.14116
4. (2022, May 19). Celox Gauze – Post Partum Hemorrhage – Retrospective Data Analysis Report V1.1. [Data on file].
5. Schmid, B. C., Rezniczek, G. A., Rolf, N., et al. (2013). Uterine packing with chitosan-covered gauze for control of postpartum hemorrhage. Am J Obstet Gynecol. 209(3), 225e1-5. doi: 10.1016/j.ajog.2013.05.055
6. Dueckelmann, A. M., et al. Uterine packing with chitosan-covered gauze compared to balloon tamponade for managing postpartum hemorrhage. European Journal of Obstetrics & Gynecology and Reproductive Biology. 240, 151–155. doi: 10.1016/j.ejogrb.2019.06.003
7. Biele, C., et al. (2022). Does the use of chitosan covered gauze for postpartum hemorrhage reduce the need for surgical therapy including hysterectomy? A databased historical cohort study. J Perinat Med. 50(8), 1078-1086. doi: 10.1515/jpm-2021-0533