CALDERA MEDICAL STATEMENT REGARDING FDA MESH ANNOUNCEMENT (PDF)
Dear Patients and Medical Professionals:
Effective April 16th, 2019, the U.S. Food and Drug Administration (FDA) ordered the only two manufacturers of Transvaginal Pelvic Organ Prolapse (POP) surgical meshes to stop all sales and distribution in the United States.
In our aim to support you in your clinical choices, we want to clarify that Vertessa® Lite is not indicated for transvaginal POP repair and Desara® is not indicated for POP repair. Neither of Caldera Medical products are affected by this FDA decision.
Furthermore, the safety and effectiveness of Abdominal Sarcocolpopexy Meshes used for treatment of POP (Vertessa® Lite) and Mesh Suburethral Slings used for surgical management of female Stress Urinary Incontinence (Desara®) have been well supported and recognized by the FDA.
We want to reinforce our commitment with physician’s training and education as they transition to other available options for prolapse repair.
At Caldera Medical, patient safety and healthcare professionals support has always been and will remain our number one priority. On behalf of all Caldera Medical employees, we thank you for your confidence in our products as we work as a team towards our Mission of Improving the Quality of Life for Women.
Jeffrey S. Hubauer
Chief Operating Officer
Caldera Medical, Inc.
April 17th, 2019
Caldera Medical and FIUGA Partner to Support Urogynecological Education, Research and Care Around the World
Agoura Hills, CA, June 1st, 2017 (PDF)
AGOURA HILLS, CA, June 01, 2017 – Foundation for International Urogynecological Assistance (FIUGA) and Caldera Medical today announced their partnership to support urogynecological education, research and care around the world to reduce the suffering of women with Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP).
Caldera Medical is a medical device company that develops differentiated surgical implants for the treatment of SUI and POP. “Millions of women in poverty-stricken countries are incapacitated by incontinence and/or prolapse and are not receiving the care they need,” stated Bryon Merade, Chairman and CEO, Caldera Medical, adding, “teaming up with FIUGA to eliminate the suffering of women with SUI and POP will enable us to fulfill our mission of improving the quality of life for women. I encourage people to show their support of FIUGA by offering a donation, https://www.statusplus.net/fiuga/donate/.”
“Caldera Medical is a great partner and this partnership reflects our desire to collaborate with companies that share our vision of a world where all women are free from pelvic floor problems. This partnership underscores our commitment to promote research, education and care of urogynecology conditions,” said Dr. Peter Sand, President, FIUGA.
FIUGA will coordinate humanitarian trips for surgeons and arrange logistics including local transportation, accommodation, customs enforcement and safety. Caldera Medical will sponsor travel and housing expenses of FIUGA’s faculty traveling on humanitarian trips. Caldera Medical aims to promote FIUGA’s goal to generate more positive support for the cause. In addition, Caldera Medical will donate surgical implants and provide reusable introducers during humanitarian trips.
About Women’s Health Initiative and Caldera Medical
Caldera Medical launched Women’s Health Initiative (WHI) to partner with leading surgeons to advance education and provide humanitarian aid while delivering care to impoverished women suffering from SUI and POP regardless of their ability to pay. The initiative specifically involves dispatching teams of surgeons to underprivileged areas to treat patients and to provide proper training to local physicians. WHI’s goal is to alleviate one million women suffering from incontinence and prolapse by 2025.
Caldera Medical’s product lines include Desara® Sling System for the treatment of SUI and Vertessa® Lite for use in abdominal sacrocolpopexy procedures for the treatment of POP. Caldera Medical is a privately held company located in Los Angeles, California. For more information, visit Caldera Medical at http://www.calderawhi.com or https://calderamedical.com.
FIUGA was founded and incorporated in 2013 in the United States as an independent tax-exempt charitable organization commissioned to support the charitable and academic activities of the International Urogynecological Association (IUGA). The main goal of FIUGA is advancing global urogynecological knowledge and practice through education and the promotion of basic and clinical research on disorders of the female pelvic floor throughout the world.
The Ghana Project – Their first project was to establish a Center of Excellence in Ghana in collaboration with the Ghanaian College of Surgeons to promote education in Female Pelvic Medicine.
IUGA eXchange Program – Through eXchange Programs, they improve the quality of life for women with pelvic floor problems around the world by teaching their care providers how to diagnose and treat pelvic floor dysfunction in underserved areas. Since 2005, 19 eXchange Programs have been held in 13 countries: Bahrain, Serbia, Thailand, China, the Philippines, South Africa, Mozambique, Kazakhstan, Malaysia, Bolivia, Jordan, Sudan, and India.
Regional Symposia – Through Regional Symposia held at major teaching centers where urogynecological services are already being provided, FIUGA further promotes the advanced education of obstetricians and gynecologists, urologists and other healthcare providers to improve their skill sets and promote research in women’s pelvic health. Venues have included Hong Kong, Slovenia, Argentina, California, Chile and Israel.
International Fellowship- FIUGA also offers fellowships, observerships, and research grants to allow for increased dissemination of urogynecological knowledge.
For more information, visit FIUGA at https://fiuga.statusplus.net/.
Caldera Medical and FIUGA Partner to Support Urogynecological Education, Research and Care Around the World (PDF)
Caldera Medical Launches Women’s Health Initiative – Company announces humanitarian initiative toward alleviating one million women suffering from Incontinence and Prolapse by 2025 (PDF)
Caldera Medical Announces FDA Clearance for new generation of Vertessa® Lite Polypropylene Mesh for Sacrocolpopexy (PDF)
Caldera Medical will attend the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Conference in Scottsdale, AZ.(PDF)
Caldera Medical Announces FDA Clearance of Vertessa™ Lite Polypropylene Mesh for Sacrocolpopexy (PDF)
Study Reports on Efficacy of Caldera Medical’s Desara® Sling System (PDF)
Caldera Medical Donates $300,000 of Product as Part of their Humanitarian Aid Program (PDF)
Caldera Medical Awarded Grant for Groundbreaking Biomedical Research (PDF)
Caldera Medical Announces New Corporate Headquarters (PDF)
Caldera Medical Donates Products for Humanitarian Aid (PDF)
Caldera Medical Elects Board of Directors(PDF)
Caldera Medical Announces FDA Clearance of Novel Treatment for Pelvic Organ Prolapse. Ascend® enables treatment of both anterior and apical prolapse in a single procedure. (PDF)
Caldera Medical Signs Patent License Agreement with Coloplast A/S (PDF)
Coloplast Press Release: Coloplast Acquires New Male Stress Incontinence Therapy (PDF)
Caldera Medical Receives CE Mark for Desara™ (PDF)
Caldera Medical Achieves ISO 13485: 2003 Certification (PDF)
American Medical Systems Signs Cross-Licensing Agreement with Caldera Medical (PDF)