Medtronic TYRX(TM) Neuro Absorbable Antibacterial Envelope now Available for Use with Implantable Neurostimulators

Medtronic TYRX(TM) Neuro Absorbable Antibacterial Envelope now Available for Use with Implantable Neurostimulators

Dublin – October 7, 2015 – Medtronic plc today announced the first implants of the TYRX(TM) Absorbable Antibacterial Envelope with Medtronic Deep Brain Stimulation (DBS) systems. The implants were conducted by Francisco Ponce, M.D., director, Barrow Center for Neuromodulation, at the Barrow Neurological Institute in Phoenix. Medtronic recently received FDA clearance for the TYRX Neuro Absorbable Antibacterial Envelope for use with implantable neurostimulators (INS), and the product is now commercially available across the United States as an option for use with all DBS systems. In the coming months, Medtronic also plans to make the TYRX Absorbable Antibacterial Envelope available as an option for use with implantable neurostimulators to treat chronic pain and bladder and bowel control disorders.

The TYRX Absorbable Antibacterial Envelope is a mesh envelope that securely holds an INS or cardiac implantable electronic device (CIED). It is designed to stabilize the device after implantation while releasing two antimicrobial agents, minocycline and rifampin, over a minimum of seven days to help prevent surgical-site infections, which are associated with substantial morbidity, mortality and cost.

New Clinical Trial Will Evaluate Antibacterial Envelope in Cardiac Implantable Electronic Device Patients at Risk for Major Infections

Medtronic Announces First Patient Enrollment in the WRAP Infection Clinical Trial
MINNEAPOLIS – Jan. 7, 2015 – Medtronic, Inc. (NYSE: MDT) today announced the first patient enrollment in the WRAP Infection Clinical Trial, which will evaluate the effectiveness of the TYRX™ Absorbable Antibacterial Envelope in reducing major infections in patients with cardiac implantable electronic devices (CIEDs) at risk for infection. The global clinical trial also will assess healthcare costs related to treatment of major infections in CIED patients. The first patient implant was performed by Edward J. Schloss, M.D., director of electrophysiology at The Christ Hospital in Cincinnati.

Medtronic Announces CE Mark and European Launch of TYRX(TM) Absorbable Antibacterial Envelope

MINNEAPOLIS – Sept. 22, 2014 – Medtronic, Inc. (NYSE: MDT) has received CE (Conformité Européenne) Mark for the TYRX(TM) Absorbable Antibacterial Envelope. This innovative mesh envelope covers an implantable cardiac device to help stabilize the device after implantation and reduce surgical-site infections.

The efficacy of the previous generation, non-absorbable TYRX(TM) Antibacterial Envelope* has been shown in three published studies, with new six-month follow-up data from the CITADEL/CENTURION Study presented at Cardiostim 2014. Six months following implantation, patients who received a single- or dual- chamber implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) replacement device with a TYRX Antibacterial Envelope experienced lower infection rates than a historical cohort of patients who were implanted without the envelope.

Medtronic Announces Acquisition of TYRX, INC., Developer of Solutions for Surgical Site Infections

MINNEAPOLIS – Jan. 06, 2014 – Medtronic, Inc. (NYSE: MDT) today announced that it has acquired TYRX, Inc., a privately held, New Jersey-based developer of implantable combination antibiotic drug and implanted medical devices. TYRX’s product offerings include the recently FDA cleared AIGISRx® R Fully Resorbable Antibacterial Envelope, designed to reduce surgical site infections associated with Cardiac Implantable Electronic Devices (CIEDs), and the AIGISRx® N Antibacterial Envelope, for use with spinal cord neuromostimulators. The all cash transaction includes an initial payment of $160 million plus potential earn out and performance based milestone payments. Medtronic expects the net impact from this transaction to be neutral to fiscal year 2014 earnings and for this transaction to be consistent with the company’s disciplined focus on long-term returns.

FDA Clears TYRX Antibacterial Envelope for Use with Spinal Cord Neuromodulators

Monmouth Junction, NJ. (December 4, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance for expanded indications in marketing the AIGISRx® N Antibacterial Envelope for use with spinal cord neuromodulators. This comes after the recent FDA clearance of the AIGISRx N for use with vagus nerve stimulators. This expanded clearance extends TYRX’s leadership in the commercialization of implantable medical devices designed to help reduce Surgical Site Infections (SSIs) associated with implantable devices in the fields of neurosurgery and cardiology.

TYRX Announces First U.S. Implantation of AIGISRx® R Fully Bioresorbable Antibacterial Envelope

 
Procedure Performed at Vanderbilt Heart and Vascular Institute

Monmouth Junction, NJ. (August 7, 2013): TYRX, Inc. announced today that the first implantation of its new AIGISRx R Fully Resorbable Antibacterial Envelope has taken place at the Vanderbilt Heart and Vascular Institute in Nashville, TN by Dr. Christopher R. Ellis. The AIGISRx R Antibacterial Envelope received U.S Food and Drug Administration (FDA) clearance on May 20, 2013.

TYRX Receives FDA Clearance for AIGISRx® Neuro Antibacterial Envelope

 
Expands Access to Proven Antibacterial Technology to Neurosurgery

Monmouth Junction, NJ. (July 23, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the AIGISRx Antibacterial Envelope for use with vagus nerve stimulators, which are currently used to treat seizure disorders and depression. This approval extends TYRX’s leadership in the
commercialization of implantable medical devices designed to help reduce surgical-site infections (SSIs) associated with implantable devices into the field of neurosurgery.

TYRX Receives FDA Clearance for Fully Resorbable AIGISRx® R Antibacterial Envelope

 
AIGISRx Antibacterial Envelope Uniquely Designed to Combat Surgical Site Infections Associated with Cardiac Implantable Electronic Devices (CIEDs)

Monmouth Junction, NJ. (July 9, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the Fully Resorbable AIGISRx R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators (ICDs). The AIGISRx Antibacterial Envelope received approval from Health Canada in January 2013.

AIGISRx is a fully bioresorbable, antibacterial mesh envelope, intended to hold CIEDs securely in place in order to provide a stable environment when implanted in the body. Key to its design, AIGISRx R contains the antimicrobial agents rifampin and minocycline, which are released locally into the tissue, to help reduce surgical site infections (SSIs) associated with CIED implantation. Multiple studies have shown that in patients at high-risk for device infection, CIED implantation with the AIGISRx Antibacterial Envelope significantly reduced device infections by 70% – 100%, compared to patients who did not receive the AIGISRx.

Zero Infections in High-Risk Cardiac Device Replacements Reported with Use of TYRX Antibacterial Envelope

 
Prospective, Multicenter Study of 532 Case Matched Patients Showed 100% Reduction in Infections

Athens, Greece (June 26, 2013): Use of TYRX, Inc.’s AIGISRx® Antibacterial Envelope reduced major infection rates by 100% in patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to case-matched retrospective control patients. Investigators presented new interim results from the Citadel / Centurion Clinical Study today at the Late Breaking Clinical Trials session at the European Heart Rhythm Association (EHRA), EUROPACE 2013.

Independent Study Shows Significant Decline in Cardiac Device Infections with TYRX® Antibacterial Envelope

New Data in High Risk Patients Presented at Heart Rhythm Society
Shows a 70% Reduction in CIED Infections

Denver, CO (May 10, 2013): Use of TYRX, Inc.’s AIGISRx® Antibacterial Envelope significantly reduced device infection rates in patients at high risk for device infection who received cardiovascular implantable electronic device (CIED) implants, according to a study presented today at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions.