Archive for month: July, 2021

Endologix, a California-based, global medical device company focussed on the treatment of vascular disease, says the company’s ChEVAS (Chimney EndoVascular Aneurysm Sealing) System has been granted a Breakthrough Device Designation from the US FDA. The ChEVAS System is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA.

The FDA Breakthrough Devices Program gives patients more timely access to medical devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Breakthrough Devices receive priority review by FDA, and the program provides opportunities for early interaction with FDA personnel to expedite the review and approval process.

ChEVAS is currently being evaluated through the ChEVAS ONE IDE (Investigational Device Exemption) clinical study that is approved to enrol approximately 120 patients at up to 50 clinical sites worldwide. The national principal investigators of the ChEVAS ONE study are Francis Caputo, MD (Cleveland Clinic Foundation); William Jordan, MD (Emory University School of Medicine); Joseph Lombardi, MD (Cooper University Health Care) and William Quinones-Baldrich, MD (UCLA).

“The aneurysm sac sealing technology featured in the ChEVAS system is designed to reduce endoleaks, including gutter endoleaks, that are reported after endovascular treatment of complex aneurysms,” explained James McKinsey, MD, the leading enroller in the ChEVAS ONE IDE study. “Our initial clinical results of this therapy have been promising in a challenging group of patients.”

Dr. McKinsey will present his initial experience with ChEVAS at the Eastern Vascular Society Annual Meeting on September 26.

Matt Thompson, MD, chief medical officer at Endologix, said: “The ChEVAS System represents an important therapy that provides an ‘off-the shelf’ treatment to an underserved patient population who have complex abdominal aortic aneurysms. We are delighted that the FDA has designated ChEVAS as a Breakthrough Device, as this will facilitate our ability to develop this technology and make it available to patients in an expedited fashion. The ChEVAS System joins the PQ Bypass DETOUR System as the two FDA-designated Breakthrough Devices in our clinical investigational programs, which is reflective of our aspiration to provide innovative and disruptive technologies to address clinically relevant therapeutic gaps.”

• For more information, visit: http://www.endologix.com/

Lumenis, a medical device company renowned for developing and commercializing innovative energy-based technologies, including laser, intense pulsed light (IPL) and radio frequency (RF), for surgical, aesthetic, and ophthalmic applications, notes that all the hospitals named to U.S. News and World Report’s Best Hospitals Honor Roll use Lumenis surgical lasers. Most of them use the company’s flagship products: Lumenis MOSES holmium laser technology and the pioneering Lumenis UltraPulse DUO CO₂ surgical laser system.

The Lumenis holmium laser with MOSES technology delivers many clinical and economic advantages for kidney stones [1] and enlarged prostate [2] – two common procedures in many hospitals. Nearly universal adoption among these 20 top hospitals shows the strong trend toward standardization to MOSES technology. With MOSES, surgeons ablate stones with up to 85% higher efficiency [3] and 20% shorter procedure times [1].

For enlarged prostate surgery, MOSES has turned gold-standard HoLEP surgery from an overnight stay into a same-day, catheter-free discharge, [4] creating a better patient experience while freeing  hospital beds for acute care. Similarly, the tissue-sparing precision of the UltraPulse DUO CO₂ laser has revolutionized challenging procedures, such as transoral microsurgery and minimally invasive treatment of uterine fibroids and endometriosis. Lumenis lasers offer multi-specialty flexibility in busy medical centres, with applications in urology, gynaecology, otolaryngology, neurology and orthopaedics.

“We are pleased to see every one of the outstanding hospitals on the Best Hospitals Honor Roll uses Lumenis surgical lasers,” said Tzipi Ozer-Armon, CEO, Lumenis. “At Lumenis, our mission is to deliver better technology for better patient care. We believe that one way to achieve this is through innovation and collaboration with leading surgeons and hospitals around the world. The end result is that Lumenis technologies are helping exceptional hospitals deliver exceptional patient care.”

References

1. Ibrahim A et al. Double-Blinded Prospective Randomized Clinical Trial Comparing Regular and MOSES Modes of Holmium Laser Lithotripsy. J Endourology. 2020;34(5):624-628.

2. Kavoussi NL et al. MOSES Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Control Trial. J Urol. 2021 Feb 22.

3. Bench test results may not necessarily be indicative of clinical performance.

4. Agarwal DK et al. Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2021 Jan 4;S2405-4569(20)30320-5.

 

• For more information, visit lumenis.com.