Contego Medical Receives 510(k) Clearance for the Paladin Carotid PTA Balloon System with Integrated Embolic Protection

Raleigh, NC (September 18, 2018) — Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first filter-based Integrated Embolic Protection (IEP) device, the Paladin® Carotid PTA Balloon System. Contego Medical is developing and commercializing a suite of next-generation devices that address unmet needs in neurovascular, coronary and peripheral [...]

By |2018-10-16T10:54:48-07:00October 16th, 2018|News|Comments Off on Contego Medical Receives 510(k) Clearance for the Paladin Carotid PTA Balloon System with Integrated Embolic Protection

Contego Medical Announces the Start of Enrollment in the PERFORMANCE I Trial

Raleigh, NC, March 7, 2018 -- Contego Medical, LLC has announced the beginning of enrollment in the PERFORMANCE I Trial, a clinical trial designed to evaluate the safety and feasibility of the Neuroguard IEPâ 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat clinically significant carotid artery stenosis, further expanding Contego Medical’s portfolio of neurovascular solutions.

By |2023-01-04T10:10:08-08:00March 7th, 2018|News|Comments Off on Contego Medical Announces the Start of Enrollment in the PERFORMANCE I Trial

Contego Medical Announces ENTRAP Study Initiation for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Raleigh, NC, (September 12, 2017) -- Contego Medical, LLC announced today the initiation of the ENTRAP Study evaluating usage of its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection in patients receiving peripheral angioplasty. First cases with the device were performed by Ralf Langhoff, M.D. at Sankt Gertrauden Krankenhaus in Berlin, Germany, with the first enrolled patient treated by Koen Deloose, M.D. at AZ Sint Blasius in Dendermonde, Belgium. The Vanguard IEP System received CE mark in April 2017.

By |2023-01-04T10:07:53-08:00September 12th, 2017|News|Comments Off on Contego Medical Announces ENTRAP Study Initiation for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Raleigh, NC, (April 27, 1017) — Contego Medical, LLC announced today that it has received CE Marking of its Vanguard IEPä Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Company intends to launch the Vanguard IEP System in Europe to endovascular specialists performing lower limb angioplasty procedures.

By |2023-01-04T10:07:24-08:00April 27th, 2017|News|Comments Off on Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Contego Medical Completes Enrollment of Paladin Clinical Registry

Raleigh, NC (July 20, 2016) — Contego Medical, LLC announced today that it has completed enrollment in the Paladin® Carotid PostDilation Balloon System Registry in Europe. The registry involved 5 centers with 100 total patients, and represents the first prospective clinical evaluation of a new class of device that provides Integrated Embolic Protection™ (IEP) technology for interventional treatment of carotid stenosis.

By |2023-01-04T10:09:21-08:00July 20th, 2016|News|Comments Off on Contego Medical Completes Enrollment of Paladin Clinical Registry

Contego Medical Announces Positive Clinical Data for Paladin System, the First Post-Dilation Balloon with Integrated Embolic Protection Technology

Data presented at the Leipzig Interventional Course (LINC) demonstrates breakthrough treatment for Carotid Artery Disease
Raleigh, NC (January 26, 2016) — Contego Medical, an innovator in developing next generation treatments for coronary and peripheral artery disease, today presented positive post-­market registry data for the Paladin® Carotid Post-­Dilation Balloon with Integrated Embolic Protection™ (IEP) Technology at LINC 2016, in Leipzig, Germany. The presentation included compelling results from a diffusion-­weighted MRI (DW-­MRI) sub-­study that showed improved patient outcomes with the Paladin System.

By |2023-01-04T10:15:38-08:00January 26th, 2016|News|Comments Off on Contego Medical Announces Positive Clinical Data for Paladin System, the First Post-Dilation Balloon with Integrated Embolic Protection Technology
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