Showing posts with label System. Show all posts
Showing posts with label System. Show all posts

Tuesday, April 30, 2013

The Acessa™ System Now Approved In Mexico To Treat Symptomatic Uterine ... - PR Newswire (press release)

AppId is over the quota
AppId is over the quota
LIVERMORE, Calif., Feb. 11, 2013 /PRNewswire/ -- Halt Medical, Inc. announced today that on January 18, 2013, COFEPRIS, a division within the Mexican Ministry of Health (Secretaria de Salud) responsible for medical device oversight, issued registration for the Acessa System to treat symptomatic uterine fibroids.

"Mexico is the second largest market for medical devices in Latin America," said Jeffrey Cohen , Halt's Chief Executive Officer. "We are very excited to have the opportunity to expand our market reach to virtually all of North America."

According to the Centers for Disease Control, fibroids are the leading cause for hysterectomy procedures worldwide. The Acessa System is used in a minimally invasive same-day surgery procedure where a slender Handpiece is used to deliver radiofrequency energy to the fibroid, after which the fibroid is re-absorbed by the surrounding tissue. Acessa treats just the fibroids, preserving the normal function of the uterus.  Patients typically go home the same day with little pain and experience rapid recovery and return to normal activities.

"The Acessa Procedure will be of great benefit to many women suffering from symptomatic uterine fibroids in Mexico," added Dr. Jose G. Garza Leal , Department of Gynecology and Obstetrics, Hospital Universitario Nuevo Leon, Monterrey, Mexico. "We look forward to the continued advancement of care for our fibroid patients with this technology."

Cohen further stated, "From Canada to Mexico, over 10 million women are at risk to the debilitating symptoms of uterine fibroids; including heavy menstrual bleeding, pain, and bulking. According to 94% of the patients in our IDE trial, their symptoms were resolved following treatment with the Acessa Procedure."

About Halt Medical, Inc.

Founded in 2004, Halt Medical is a medical device company focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Company has developed and launched the Acessa System and Procedure, using radiofrequency energy to destroy uterine fibroids. The results of both U.S. and international trials have led to the clearance of the product by the FDA for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa System also has regulatory approval to treat symptomatic uterine fibroids in the European Union, Canada, and Mexico. The Company is located in Brentwood, CA.  For information about the Acessa System, please visit www.haltmedical.com.

SOURCE Halt Medical, Inc.

RELATED LINKS
http://www.haltmedical.com


View the original article here

Monday, March 18, 2013

Halt Medical Announces The First Commercial Use Of the Acessa(TM) System - MarketWatch (press release)

AppId is over the quota
AppId is over the quota

LIVERMORE, Calif., March 12, 2013 /PRNewswire via COMTEX/ -- Halt Medical, Inc. announced that Dr. Jay M. Berman, M.D., FACOG, has performed the first commercial Acessa Procedure in the United States. The procedure is used for the treatment of uterine fibroids. Dr. Berman performed the procedure at the Berry Surgery Center in Farmington Hills, MI, an outpatient facility affiliated with the Detroit Medical Center's DMC Sinai-Grace Hospital.

"We are extremely happy that Dr. Berman, the Wayne State University Physician Group and Detroit Medical Center have begun introducing their patients to the Acessa Procedure," said Jeffrey M. Cohen, Halt Medical CEO. "The Acessa Procedure represents a major breakthrough in addressing one of the biggest unmet needs in women's health, uterine fibroids. Acessa is the only medical device that can be used by gynecologists to treat all fibroids."

Dr. Berman said, "Approximately 50 to 70 percent of women have uterine fibroids. Before the Acessa Technology, treatment involved cutting through layers of healthy tissue to gain access to the fibroids, or removing the uterus completely through a hysterectomy. However, research shows the majority of women choose to suffer through their symptoms rather than undergo surgery." Dr. Berman is Associate Professor, Director, Division of Gynecology, Department of Obstetrics and Gynecology, Wayne State University School of Medicine and Associate Chief Medical Officer, Clinical Operations, Wayne State University Physician Group.

The Acessa Procedure is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. After treatment, the fibroid is re-absorbed by the surrounding tissue. Acessa allows the surgeon to treat only the fibroids, while preserving normal function of the uterus. Patients typically go home the same day with little pain, and enjoy a rapid return to normal activities. More than 250 women have been successfully treated with Acessa.

"Any technology that gives us the ability to give women choices, in this case that spares the uterus and avoids the need for hysterectomy, has merit," said L. Andrea Coleman, M.D., chief of Obstetrics and Gynecology at DMC Sinai-Grace Hospital. "Sinai-Grace and the DMC have some of the best physicians in the country, and this is evidence of that. I applaud us for always being on the forefront of technology and for doing the work that is required to stay there."

About Halt Medical, Inc.

Founded in 2004, Halt Medical is a medical device company focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Company has developed and launched the Acessa System and Procedure, using radiofrequency energy to destroy uterine fibroids. The results of both U.S. and international trials have led to the clearance of the product by the FDA for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa System also has regulatory approval to treat symptomatic uterine fibroids in the European Union, Canada, and Mexico. The Company is located in Brentwood, CA. For information about the Acessa System, please visit www.haltmedical.com. To connect with Halt Medical on Facebook visit www.facebook.com/acessasystem or on Twitter at www.twitter.com/acessasystem.

About Wayne State University Physician Group

The Wayne State University Physician Group (WSUPG) is one of southeast Michigan's largest non-profit multi-specialty physician practice groups, with more than 2,000 physicians providing primary and specialty medical services in close to 1 million patient visits annually. WSUPG has more than 100 locations, and affiliations with the Detroit Medical Center, Oakwood Healthcare System, Karmanos Cancer Center, Crittenton Hospital Medical Center, St. Joseph Mercy Oakland and St. John Providence Health System. As faculty members of the Wayne State University School of Medicine, WSUPG's physicians and staff are on the forefront of technology and bringing the latest in medical advancements to the bedside. In addition to its substantial clinical practice, WSUPG is training the Michigan physicians of tomorrow by providing instructors for more than 1,200 medical students and 900 residents each year. For more information or to make an appointment with a WSUPG doctor visit www.upgdocs.org. To connect with the Wayne State University Physician Group on Facebook visit www.facebook.com/wsupgdocs or on Twitter at www.twitter.com/wsupgdocs.

About DMC Sinai-Grace Hospital

DMC Sinai-Grace Hospital is a full-service hospital with 404 licensed beds and more than 700 physicians, 700 nurses, and 1,700 support staff. Services and capabilities include cardiology, emergency medicine, obstetrics and gynecology, urological services, psychiatry, radiation oncology, gerontology, physical medicine, and orthopedic surgery. Servicing more than 214,000 patients annually, Sinai-Grace also operates 25 ambulatory sites and surgery centers, including the Lahser and Berry Surgery Centers. Sinai-Grace serves as a teaching facility to more than 200 medical students each year, and is one of eight hospitals operated by the Detroit Medical Center (DMC). The DMC is proud to be the official health care services provider for the Detroit Tigers, Detroit Red Wings, and Detroit Pistons. For more information, visit www.sinaigrace.org. "Like" us on Facebook at www.facebook.com/sinaigrace or follow us on Twitter at @DMC_SinaiGrace.

SOURCE Halt Medical, Inc.

http://rt.prnewswire.com/rt.gif?NewsItemId=LA74924&Transmission_Id=201303120300PR_NEWS_USPR_____LA74924&DateId=20130312

Copyright (C) 2013 PR Newswire. All rights reserved

Comtex

View the original article here