News | Cardiovascular Ultrasound | August 09, 2022

Butterfly Medical Announces First BPH Clinical Study Procedures Performed in North America for its Next Generation Minimally Invasive Solution

First procedures were successfully performed under local anesthesia in an office setting by Steven Gange MD FACS, Summit Urology, Utah. 

Butterfly Medical Announces First BPH Clinical Study Procedures Performed in North America for its Next Generation Minimally Invasive Solution

August 9, 2022 — Butterfly Medical, an Israeli medical device company developing a novel minimally invasive solution to treat Benign Prostatic Hyperplasia (BPH), today announced its first procedures performed in-office under local anesthesia in its clinical study in North America. 

The clinical study evaluates the safety and effectiveness of Butterfly’s next generation prostatic retraction device: a proprietary nitinol implant designed to gently open and prevent the blockage from an enlarged prostate for improved urine flow and thereby alleviate the symptoms caused by BPH. It is considered a “next gen” BPH therapy as it is reversible while also not requiring heating, cooling, cutting or piercing of the prostate. 

The first North American procedures were successfully performed by Dr. Steven Gange, (Salt Lake City, UT) clinical study Principal Investigator. 

“Many men suffer severe urinary symptoms due to BPH, while also tolerating side effects of marginally effective medications. Today’s primary treatment is surgery, which many patients do not want,” said Dr. Steven Gange, board-certified urologist by the American Board of Urology. “This creates an excellent niche opportunity for minimally invasive BPH procedures like the Butterfly implant.” 

The Butterfly procedure can be conducted under local anesthesia in an office setting usually in less than 10 minutes. It allows for faster recovery and reduced side effects such as retrograde ejaculation, pelvic pain and, removes the need for a catheter compared to previous BPH treatments. 

“BPH impacts nearly 60% of men over the age of 60 and continues to progress well into the patient’s 80’s and 90’s,” said Idan Geva, Butterfly Medical CEO. “With growing clinical experience in Israel and Europe, we are excited to conduct our first clinical procedures in North America and provide opportunity for men to receive the Butterfly option. These are the first Butterfly procedures ever performed under local anesthesia and in an office setting, exemplifying the minimally invasive nature of the Butterfly platform.” 

The Butterfly technology is investigational in the U.S. thus only available for appropriate patients who opt to participate in the FDA clinical trial. Dr. Steven Gange, Summit Urology, is the first physician in the Utah area and one of only a handful of sites in the U.S. to currently offer this novel urology platform to their patients. 

The Butterfly Pivotal Study

The Butterfly Pivotal Study is a prospective, multi-center, blind, randomized controlled study to evaluate the safety and efficacy of the Butterfly Medical prostatic retraction device in BPH patients. Butterfly will enroll 222 participants across 15-20 investigational sites in the US. Patients will be blindly randomized to either receive the Butterfly system or undergo a sham cystoscopy procedure. After three months, patients will be unblinded and participants who underwent the sham procedure may receive treatment with the Butterfly device. Primary effectiveness will be evaluated using the International Prostate Symptom Score (IPSS) and based on the change between groups at three months and from the subject's baseline measurement at the twelve months. 

 

For more information: http://www.butterfly-medical.com 


Related Content

News | Cardiovascular Business

January 24, 2023 — Cardiothoracic surgeon Thomas E. MacGillivray, MD, from MedStar Health, was elected President of The ...

Home January 24, 2023
Home
News | Cardiovascular Business

January 19, 2023 — The volunteers and staff of the American Heart Association and the American Stroke Association are ...

Home January 19, 2023
Home
News | Cardiovascular Business

January 19, 2023 — Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat ...

Home January 19, 2023
Home
News | Cardiovascular Business

January 11, 2023 — The Alameda, Calif.-based global healthcare company Penumbra has announced U.S. Food & Drug ...

Home January 11, 2023
Home
News | Cardiovascular Business

January 9, 2023 — CinCor Pharma, Inc. announced that it has entered into a definitive agreement with AstraZeneca under ...

Home January 09, 2023
Home
News | Cardiovascular Business

January 9, 2023 — ReCor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. announced the appointment ...

Home January 09, 2023
Home
News | Cardiovascular Business

January 5, 2023 — StreamlineMD has provided updates for 2023 Radiology and IR CPT coding, which may impact your practice ...

Home January 05, 2023
Home
Feature | Cardiovascular Business | By Melinda Taschetta-Millane

As 2022 comes to a close, the Diagnostic and Interventional Cardiology team takes a look at the year's most viewed ...

Home January 02, 2023
Home
News | Cardiovascular Business

December 27, 2022 — President Joe Biden signed into law the Cardiovascular Advances in Research and Opportunities Legacy ...

Home December 27, 2022
Home
News | Cardiovascular Business

December 22, 2022 — Johnson & Johnson today announced it has completed its acquisition of Abiomed, Inc. Abiomed is now ...

Home December 22, 2022
Home
Subscribe Now