New Study Shows Accelerated Health with Medtronic’s TYRX Envelope

New data, recently published in the journal Heart Rhythm,¹ and presented at Heart Rhythm 2024,² showed positive results for the Medtronic TYRX Absorbable Antibacterial Envelope (TYRX envelope).
 
The TYRX envelope is the only absorbable antibacterial envelope with proven infection reduction and sustained pocket health benefits for those who need a cardiac implantable electronic device (CIED). 
 
The Medtronic TYRX Absorbable Antibacterial Envelope stabilizes an implanted CIED or implantable neurostimulator and supports the formation of a stable, thin, fibrous capsule. The TYRX envelope elutes the antimicrobial agent’s rifampin and minocycline, which are effective against the bacteria most causative of device infection.³
 
The Pocket Health study (NCT05356546) is the first comprehensive, prospective clinical evaluation of long-term pocket healing in the presence of an absorbable antibacterial envelope. This global, multicenter, single-arm study found that seven years after implant, the TYRX envelope may have clinical benefits beyond infection prevention. Key benefits included low chronic inflammation, clinically insignificant calcification, and conditions indicative of a strong, healed pocket.
 
the global WRAP-IT randomized trial included nearly 7,000 patients and was published in The New England Journal of Medicine.³ 
 
Primary results demonstrated the TYRX envelope reduced the risk of major infections by 40% in patients with CIEDs and reduced pocket infections by 61% when used as adjunctive therapy in addition to standard-of-care infection-prevention strategies.³ 
 
The trial also met its safety objective. The envelope did not increase the risk of complications through 12 months; 12 these results were sustained out to three years.⁴ 
 
The TYRX Absorbable Antibacterial Envelope was cleared by the FDA in 2013, and received CE Mark in 2014 for use with CIEDs, and FDA cleared in 2015 for use with implantable neurostimulators.
 
References:
¹ Virmani R, et al. Effects of envelopes on cardiac implantable electronic device pocket healing: A head-to-head preclinical evaluation. https://doi.org/10.1016/j.hrthm.2024.02.054
² Philippon F, et al. Absorbable antibacterial envelope promotes development of a healthy CIED pocket. 2024 HRS conference poster presentation.
³ Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial envelope to prevent cardiac implantable device infection. N Engl J Med 2019;380:1895–1905.
⁴ Mittal S, Wilkoff BL, Kennergren C, et al. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: long-term follow-up. Heart Rhythm 2020;17:1115–1122.