News & Events
November 15, 2018
IRVING, TEXAS (November 15, 2018) – Thermi®, an Almirall, S.A. company, today announced that it has received a notice of completion to a U.S. Food and Drug Administration (FDA) inquiry on products used in “vaginal rejuvenation” procedures.
Thermi received an “It has come to our attention” notice from the FDA on July 24, 2018 regarding specific claims about the company’s ThermiVa® device in the United States. ThermiVa, a non-ablative radiofrequency application, has been cleared by the FDA for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. All Thermi products are marketed in accordance with their FDA-cleared indications, and Thermi supports a professional training program to ensure appropriate use of all ThermiRF® devices.
A non-invasive, non-surgical, non-hormonal treatment, ThermiVa uses temperature-controlled radiofrequency energy to gently heat tissue. The in-office treatment which is cleared by the FDA, is available in more than 36 countries globally and has been used in more than 100,000 procedures worldwide.
“We are pleased to make this announcement and to have worked collaboratively and constructively with the FDA to address their inquiry,” said Thermi VP of Global Medical Affairs, Dr. Tara Margarella. “We will continue to maintain and further develop our relationship to ensure compliance to the agency’s directives and guidance for future clinical indications for use with all of the Thermi® products.”
ThermiVa is supported by clinicians worldwide and Thermi is committed to the continued investment and development of robust clinical programs to demonstrate and validate ThermiVa’s capabilities for various indications.
Thermi, an Almirall Company, is a leading global manufacturer of temperature-controlled radiofrequency technology. The company’s flagship product is ThermiRF®, a platform technology that uses temperature as an endpoint for various minimally and non-invasive applications (ThermiTight®, ThermiRase®, ThermiSmooth® Face, ThermiVa®, etc.). Thermi also offers the Thermi250™ device as the newest innovative RF for body. Founded in 2012, Thermi is a US based company with its headquarters in Irving, Texas and R&D in Boston, MA.
For more information, please visit www.thermi.com
Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed.
The company, founded in 1943 and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenues in 2016 were 859.3 million euros. More than 2,000 employees are devoted to Science.
To learn more about Thermi and what its technology can offer, please visit www.thermi.com.
September 17, 2018
Dr. Andrea Pezzella has recently completed her training under Dr. Red M. Alinsod at the Alinson Institute for Aesthetic Vulvovaginal Surgery, Laguna Beach, California. Dr. Pezzella is committed to new and innovative technology, refining her skills and improving her knowledge for the patients of Southern Urogynecology. Provide all emcompassing female pelvic and intimate health, she now can offer restorative vaginal rejuvenation surgery as well as the O-Shot® for increasing sensitivity and increasing support in the vagina tissues.
With her training, Dr. Pezzella has completed the Advanced Master’s Surgical Preceptorship in Aesthetic Vulvovaginal Surgery and Non-invasive Radiofrequency Therapies. This training involved extensive didactic and surgical training in a wide variety of aesthetic vulvovaginal procedures, such as labia minoraplasty, majoraplasty, clitoral hood reduction, hymenoplasty, vaginoplasty, to mention just a few of the many vulvovaginal treatments she successfully completed training for. She also successfully completed training for radiofrequency therapies, a ground-breaking and effective non-invasive surgical innovation developed by Dr. Alinsod.
Dr. Red Alinson is one of the most experienced aesthetic vulvovaginal physicians in the United States and worldwide, with over three decades of medical experience. In addition to a successful private gynecological practice in Laguna Beach, he has invented and patented a number of vaginal surgery devices that are being used by surgeons all over the world. His institute, the AIAVS, has been highly-sought after by physicians from Harvard, Stanford, Yale, and other medical schools looking to be trained one-to-one by one of the best aesthetic vulvovaginal physicians in the country. It is a privilege by Dr. Andrea Pezzella to have completed a prestigious preceptorship with a master of the field.
Cynosure Letter to Customers
August 2, 2018
Dear Valued Customer,
On July 30, 2018 the FDA issued a statement expressing concerns regarding “vaginal rejuvenation” procedures using energy-based devices and submitted letters to seven companies who manufacture such devices, including Cynosure Inc., a division of Hologic Inc. It is our understanding that the letters received by each company vary in content and concerns as each of the products referenced by FDA have distinct clearances and claims. The letter received by Hologic did not question the safety of the device but did question some of the claims located on our website and whether our existing 510(k) clearances adequately include those claims. As a leader in women’s health, Hologic has a strong track record of developing products based on science and clinical evidence as well as meeting our regulatory obligations and so we take the contents of this letter seriously.
As a reminder, the SMARTXIDE2 Laser System (MonaLisa Touch) was cleared on September 5, 2014 by the FDA for indications that include gynaecology applications; specifically, incision, excision, ablation, vaporization, and coagulation of the body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, gynaecology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery, and genitourinary surgery.
We are evaluating the concerns raised in the letter and we intend to work collaboratively with the agency to respond to their questions. We are committed to marketing our products in compliance with FDA requirements and believe a higher level of scrutiny from regulatory authorities will benefit our customers. Given our strength in women’s health, the many studies completed on MLT, and our efforts to demonstrate the clinical value of all our products, we are well-poised to be a leader in this area.
We share the same goals as FDA – clinically strong products that improve patient lives and are marketed responsibly.
If you have additional questions call (844) 365-5060 or email cynosureclinicalsupport@Hologic.com.
President, Cynosure, Inc.
Boston Scientific Responds to Mesh Safety
Recently, there was a 60 Minutes report on the safety of mesh used to relieve the symptoms of pelvic floor prolapses and urinary incontinence. One of the manufacturers of mesh products, Boston Scientific, has released a statement addressing some of the questions raised in the report. The company and the CEO stands by the safety and quality of the products they manufacture and provide to women whose lives are affected by the symptoms of prolapse. Please watch the video on the left to learn more.
To learn more about how your pelvic floor prolapse or urinary incontinence can be managed, contact us at Southern Urogynecology to learn more about your treatment options.
First Patients Implanted at Southern Urogynecology with Axonics® Sacral Neuromodulation System for Urinary Incontinence
Columbia, SC – March 5, 2018 – Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNMTM) system for the treatment of urinary and bowel dysfunction, today announced that Dr. Andrea Pezzella implanted the first patient at Southern Urogynecology at Columbia, SC as part of the ARTISAN-SNM study. READ MORE
AUGS recently became aware that, on Sunday, May 13th, “60 Minutes” will be airing a segment on mesh injuries. We know that some of the content will include interviews with patients; beyond that, we don’t know what to expect. We should be prepared, however, for a public reaction, and another layer of anxiety that our patients bring with them into our offices… READ MORE
After extensive review of data and information from various sources available to the FDA, including data and information from Boston Scientific and results from the FDA’s own testing of the finished product, the FDA has determined that the change in supplier of the polypropylene… READ MORE