Transcervical

Gynesonics Announces Positive Coverage Policy Decision Published by Cigna for Treatment of Uterine Fibroids with the Sonata System

Retrieved on: 
Thursday, June 3, 2021
Professional services, Health, Medical devices, Surgery, Insurance, Managed care, General Health, Medicine, Clinical medicine, Medical specialties, Gynaecological neoplasia, Uterine fibroid, Surgical oncology, Interventional radiology, Gynecological surgery, Transcervical, Radiofrequency ablation, Uterus, Ablation, Sonata System, Gynesonics, SONATA SYSTEM, GYNESONICS

The Sonata technology platform integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.

Key Points: 
  • The Sonata technology platform integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.
  • Fibroids are treated from within the uterus, so treatment with the Sonata System requires no incisions, no tissue is surgically removed, and the uterus is retained.
  • This policy opens the way for their members to have the Sonata Procedure, the least invasive radio frequency ablation treatment for uterine fibroids, said Chris Owens, President and CEO of Gynesonics.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

New Guidance from the American College of Obstetricians and Gynecologists for Fibroid Management Supports Incisionless Transcervical Radiofrequency Ablation as a Uterus-Preserving Treatment Option

Retrieved on: 
Tuesday, June 1, 2021
Surgery, Women, FDA, Clinical trials, Biotechnology, Other Health, Health, Consumer, Pharmaceutical, Medicine, Clinical medicine, Neoplasms, Interventional radiology, Gynaecological neoplasia, Uterine fibroid, Radiofrequency ablation, Transcervical, Ablation, Sonata System, Gynesonics, SONATA SYSTEM, GYNESONICS

We are pleased that ACOG included transcervical radiofrequency ablation of fibroids in their Practice Bulletin.

Key Points: 
  • We are pleased that ACOG included transcervical radiofrequency ablation of fibroids in their Practice Bulletin.
  • This comes on the heels of the two-part expert consensus recommendation of a new fibroid treatment algorithm in Europe incorporating transcervical radiofrequency ablation.
  • Im particularly pleased to see ACOG recognize the efficacy of transcervical radiofrequency ablation of fibroids.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces Positive Payer Coverage Issued by Health Care Service Corporation (HCSC) for the Sonata Treatment

Retrieved on: 
Monday, March 15, 2021
Women, Insurance, Surgery, General Health, Health, Medical devices, Professional services, Consumer, Clinical medicine, Medicine, Medical specialties, Gynecological surgery, Gynaecological neoplasia, Uterine fibroid, Uterine myomectomy, Hysterectomy, Uterus, Transcervical, Fibroid, Uterine artery embolization, Sonata System, Gynesonics

Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Health Care Service Corporation (HCSC) has released a coverage policy for The Sonata Procedure.

Key Points: 
  • Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Health Care Service Corporation (HCSC) has released a coverage policy for The Sonata Procedure.
  • The Sonata Treatment is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations.
  • Fibroids are treated from inside the uterus, so the Sonata Treatment requires no incisions, no tissue is surgically removed, and the uterus is preserved.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces Centers for Medicare and Medicaid Services Final Rule Approves Ambulatory Surgery Centers as a Site of Service for Transcervical Uterine Fibroid Ablation with Device Intensive Designation

Retrieved on: 
Tuesday, March 9, 2021
Health, Medical devices, Consumer, Women, Surgery, Other Health, General Health, Medicine, Clinical medicine, Medical specialties, Gynaecological neoplasia, Uterine fibroid, Transcervical, Minimally invasive procedure, Gynecological surgery, Uterine artery embolization, Hysterectomy, Sonata System, Gynesonics

For Sonata procedures performed in a hospital outpatient setting, Ambulatory Payment Classification (APC) 5416 has increased to $6,794.31.

Key Points: 
  • For Sonata procedures performed in a hospital outpatient setting, Ambulatory Payment Classification (APC) 5416 has increased to $6,794.31.
  • The advantages of this minimally invasive, incision-free, uterus preserving procedure allows women to have a faster recovery than more invasive options.
  • Creating access in an ASC also helps drive down the overall cost of care, especially compared to alternative procedures.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces That Detroit Medical Center Huron Valley-Sinai Hospital has Introduced Sonata, A New Innovative, Incision-Free Treatment for Symptomatic Uterine Fibroids

Retrieved on: 
Thursday, January 21, 2021
Health, Medical devices, Consumer, Women, Surgery, Other Health, General Health, Detroit Medical Center, Tenet Healthcare, Neoplasms, Benign neoplasms, Medicine, Gynaecological neoplasia, Uterine fibroid, Clinical medicine, Sinai-Grace Hospital, Huron Valley-Sinai Hospital, Transcervical, Uterine artery embolization, Sonata System, Gynesonics

Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Detroit Medical Center (DMC) Huron Valley-Sinai Hospital is the first hospital in Michigan to introduce the Sonata Procedure.

Key Points: 
  • Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Detroit Medical Center (DMC) Huron Valley-Sinai Hospital is the first hospital in Michigan to introduce the Sonata Procedure.
  • Symptoms may worsen over time if fibroids are left untreated, which leads to more than two million women in the U.S. undergoing treatment for uterine fibroids each year.
  • I was very impressed by the results of the clinical studies, and the positive impact Sonata had on womens lives.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces Publication of Long Term Three-Year Results of the SONATA FDA IDE Pivotal Trial

Retrieved on: 
Tuesday, October 13, 2020
Medical devices, Health, Consumer, Surgery, Women, Clinical trials, Medicine, Clinical medicine, Gynaecological neoplasia, RTT, Uterine fibroid, Health, Transcervical, Pivotal trial, Minimally invasive procedure, Sonata System, Gynesonics

I wanted to be an investigator in the SONATA trial because of the advancement the Sonata technology represents as a minimally invasive, transcervical fibroid treatment.

Key Points: 
  • I wanted to be an investigator in the SONATA trial because of the advancement the Sonata technology represents as a minimally invasive, transcervical fibroid treatment.
  • Early in the trial, it was easy to see the patient benefits provided by Sonata.
  • These markedly improved and sustained clinical outcomes through three years in the SONATA Pivotal Trial have been well-received by the physician community.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces Publication of OPEN Clinical Trial Results, Demonstrating No Intrauterine Adhesion Formation Following Treatment with the Sonata System

Retrieved on: 
Thursday, August 20, 2020
Women, Radiology, Biotechnology, General Health, Health, Medical devices, Consumer, Clinical trials, Medicine, Clinical medicine, Medical specialties, Medical terminology, Gynaecological neoplasia, RTT, Uterine fibroid, Interventional radiology, Asherman's syndrome, Radiofrequency ablation, Transcervical, Uterus, Sonata System, Gynesonics

Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced the publication of the OPEN clinical trial results, demonstrating a lack of intrauterine adhesion formation after Transcervical Fibroid Ablation (TFA) with the Sonata System.

Key Points: 
  • Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced the publication of the OPEN clinical trial results, demonstrating a lack of intrauterine adhesion formation after Transcervical Fibroid Ablation (TFA) with the Sonata System.
  • The OPEN trial included women with apposing fibroids, all of whom were free from intrauterine adhesions after TFA.
  • The Sonata technology platform integrates the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces Rapid Expansion in Positive Payer Coverage for Sonata

Retrieved on: 
Monday, July 20, 2020
Professional services, Health, Medical devices, Consumer, Women, Surgery, Insurance, RTT, Gynaecological neoplasia, Uterine fibroid, Transcervical, Torso, Uterus, Clinical medicine, Medicine, Sonata System, Gynesonics

As an incisionless, intrauterine, uterus-preserving option, Sonata achieves all that I imagined, and more.

Key Points: 
  • As an incisionless, intrauterine, uterus-preserving option, Sonata achieves all that I imagined, and more.
  • Our mission is to provide access for all women to the Sonata treatment, and this progress with payer coverage is an acceleration of that access.
  • We see strong engagement with health insurance companies in addressing the needs of patients and initiating positive coverage for Sonata, said Chris Owens, CEO of Gynesonics.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Gynesonics Announces Publication of CHOICES: A Comparative Study of the Sonata Treatment VERSUS Myomectomy

Retrieved on: 
Tuesday, June 30, 2020
Health, Consumer, Pharmaceutical, Surgery, Publishing, Practice Management, Research, Medical devices, General Health, Hospitals, Communications, Science, Women, Clinical trials, Medicine, Clinical medicine, Medical specialties, Gynecological surgery, Uterine myomectomy, Uterine fibroid, Endoscopy, Laparoscopy, Anesthesia, Perioperative, Transcervical, Sonata System, Gynesonics

The study compared the short-term resource utilization, facility costs, and perioperative patient outcomes for transcervical fibroid ablation (TFA) using the Sonata system compared to myomectomy.

Key Points: 
  • The study compared the short-term resource utilization, facility costs, and perioperative patient outcomes for transcervical fibroid ablation (TFA) using the Sonata system compared to myomectomy.
  • All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA with Sonata.
  • TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.
  • CHOICES, an essential head-to-head comparator study, now demonstrates the procedural cost and early patient outcome advantages provided by Sonata over myomectomy.