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Aspivix announces first successful transcervical surgery

Aspivix announces first successful transcervical surgery

 


Aspivix is ​​an atraumatic, FDA-approved cervical stabilizer designed to minimize pain and bleeding and intended to replace traditional cervical ligaments.IUD placement and transcervical procedures using Carevix announced that the first patient benefited from the success.

First patient to undergo successful surgery in the United States

The first gentle procedure was performed by Dr. Alyssa M. Conklin. Assistant Professor of Clinical Obstetrics and Gynecology at Indiana University School of Medicine.

Dr. Conklin said the procedure was easily performed and provided excellent suction and traction, allowing for proper access without difficulty. The patient reported significantly less pain and no bleeding compared to previous procedures using traditional claws.

“The suction was perfectly adequate and easy to use, even in non-traditional positions! The Carebix made it easy to place the IUD when it would have been possible to do so without traction on the cervix. We did it,” Dr. Conklin said. “There was no bleeding when the suction was removed, so we were able to quickly cut the cord and remove the speculum, which shortened the surgery time. The patient had previously had an IUD, but this device I told him that I had a much better experience than last time! “

“It was better than having an IUD inserted beforehand because it was basically painless!” shared the first patient who was happy with the procedure, which felt more comfortable. “I'm glad that research is being done to reduce pain in women!”

The CarevixAmbassador program allows obstetricians, midwives, and nurses from Indiana and 12 centers of excellence around the world (USA, France, Sweden, Switzerland, and Germany) to use Carevixin's routine gynecological procedures. and provide a better experience for women.

This program showcases our commitment to innovation, fostering collaboration, and improving patient outcomes by improving our products in the clinical setting. Ikram Gard, Aspivix's US Managing Director, said:

New clinical research in the US to improve women's health

In addition to the Ambassador Program, IU School of Medicine researchers have consented the nation's first patients to a clinical study focusing on a suction cervical stabilizer compared to the standard tenaculum in intrauterine surgery.

The purpose of this clinical study is to evaluate patient-reported pain, bleeding, and device efficiency, along with provider satisfaction and ease of use during an in utero procedure using Carevixor, a monodentate ligament. .

This U.S. clinical study complements the Swiss ADVANCE Women study, which tested 100 women undergoing intrauterine device (IUD) placement using Carevixto versus standard cervical ligament use. It complements the Swiss ADVANCE Women study, a single-blind, randomized study conducted at Geneva University Hospitals, comparing Results published in the journal Contraception show that compared to single-tooth barbs for intrauterine device insertion, Carevix reduces pain by up to 73% and reduces the incidence of bleeding by 78%. is shown.

This new clinical trial, led by the IU School of Medicine, expands the scope of all intrauterine procedures, including hysteroscopy, ultrasound hysterography, and endometrial biopsies, not just IUD insertion.

Sources

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2/ https://www.med-technews.com/news/medical-device-news/first-successful-iud-and-transcervical-procedures-performed-/

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