Bolton Medical

Bolton Medical Completes Patient Enrollment in EVAR Trial

Bolton Medical, a subsidiary of Werfen Life Group out of Sunrise, Florida, has begun trialing its 58yjppbk Treovance Endovascular Abdominal Stent Graft Being Implanted in Initial PatientsTreovance endovascular abdominal stent graft on patients with infrarenal aortic aneurysms in hopes of receiving U.S. and European approvals. Additionally, the graft just saw its first use in Latin America on a patient with AAA.

Some details about Treovance from the latest press release:

• Adaptability – the 3-piece modular system can accommodate a wide-range of anatomies.

• Unique Active Fixation – surprarenal and infrarenal barbs allow for proximal and supplemental fixation in highly angulated necks.

• Highly Flexible Design – making it conformable in difficult anatomies.

The Treovance Abdominal Stent-Graft is offered with the Navitel Delivery System, an intuitive low profile system with a mechanical advantage and a completely detachable sheath assembly. The Navitel Delivery System also

includes the reliable proximal clasping system of the Relay Thoracic Stent-Graft which provides accurate deployment.

For Immediate Release January 11, 2012

Bolton Medical Announces Completion of patient enrollment for

the ADVANCE Clinical Study

Barcelona, ES—Bolton Medical announced it has completed enrollment of its

ADVANCE European Clinical Study to evaluate the safety and efficacy of the

Treovance Abdominal Stent-Graft with Navitel Delivery System for use in

endovascular aortic repair (EVAR) of abdominal aortic aneurysms. Physicians at

five hospitals across Europe have enrolled thirty patients. The final case was

performed by Dr. Vicente Riambau at Hospital Clinic of Barcelona, Spain.

“The Bolton ADVANCE study has been completed and so far the device shows

promising results”, said Prof. Roberto Chiesa, Principal Investigator for the

ADVANCE Study “I think that the Treovance Abdominal Sten-Graft continues a

new generation of devices focused on providing: low-profile systems, precise

deployment, stent-graft repositioning and additionally offers features to minimize

late disconnections”

With its accurate deployment, flexible design, multiple fixation points and wide

range of sizes, the Treovance Abdominal Stent-Graft offers many advantages to

EVAR patients. The low profile Navitel Delivery System is equipped with a

detachable sheath and allows for controlled or rapid deployment of the

Treovance Abdominal Stent-Graft. The Study included thirty patients from five

facilities throughout Europe. Prof. Gioacchino Coppi (Nuovo Ospedale di St.

Agostino-Estense, Modena, Italy), Dr. Burkhart Zipfel (Deutsches Herzzentrum

Berlin, Germany) and Dr. Secundino Llagostera – Dr. Carlos Esteban (Hospital

German Trias i Puyol, Badalona, Spain) complete the list of investigators

participating in the study.

For more information on the Treovance device and clinical trial, please visit www.

treovance.com

COMPANY

Bolton Medical currently manufactures Relay Plus and Relay NBS Plus Thoracic

Stent-Grafts. They are indicated for the treatment of main thoracic aortic

pathologies such as aneurysms, penetrating ulcers, pseudoaneurysms, and

intramural hematomas in International Market. To date, approximately 6,000

Relay and Relay NBS Stent-Grafts have been implanted worldwide. Bolton

anticipates US FDA approval of Relay in 2012. For more information on Relay

U.S. trial, please visit www.relayclinicaltrial.com.

Bolton Medical is a private company, with European operations based in

Barcelona, Spain, and U.S. operations in Sunrise, Florida. Bolton Medical is a

wholly-owned subsidiary of the Werfen Life Group, a diverse manufacturer and

supplier of products for the medical industry.

www.boltonmedical.com

Public Relations Contacts:

Aneurysms of the abdominal aorta have traditionally required an open approach, a high-risk and bloody surgery with a long recovery time. In recent years this practice has been supplanted in certain patient populations by endovascular aortic repair (EVAR). In this approach, a graft is introduced into the aorta through the femoral artery, requiring a shorter hospital stay and less blood loss. treovance bolton medical Bolton Medical Completes Patient Enrollment in EVAR TrialOne company actively involved in this field is Bolton Medical, based out of Florida and Barcelona. We last reported on their Treovance Abominal Stent-Graft in May 2011, when the ADVANCE trial of this device first started (link). Now, patient enrollment has been completed, and the results are reported to be encouraging, although the final data isn’t available yet.

“The Bolton ADVANCE study has been completed and so far the device shows promising results”, said Prof. Roberto Chiesa, Principal Investigator for the ADVANCE Study “I think that the Treovance Abdominal Stent-Graft continues a new generation of devices focused on providing: low-profile systems, precise

deployment, stent-graft repositioning and additionally offers features to minimize late disconnections”

The Treovance system is used with the Navitel delivery system, a low profile set-up with a sheath that detaches completely. The stent-graft is available in varying sizes and is flexible enough to use in patients with aortas that are difficult to navigate. Additionally, multiple fixation points, both supra- and infra-renal, are available for securing the stent-graft within the native aorta. In addition to the Treovance system for abdominal aortic pathology, the company manufactures a stent for thoracic aortic aneurysms called the Relay thoracic stent-graft, which is currently under investigative use in the United States.

Source : http://medgadget.com/2011/05/treovance_endovascular_abdominal_stent_graft_being_implanted_in_initial_patients.html

Related Posts Plugin for WordPress, Blogger...
Be Sociable, Share!

About the Author

has written 1822 posts on this blog.

Copyright © 2017 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes