October 28, 2019 – A Medtronic product that studies show reduces the rate of infection in patients who receive certain implanted medical devices is the among the top medical innovations for 2020, according to the Cleveland Clinic.

Millions of people have received implantable devices, such as pacemakers and defibrillators, but 1 to 4 percent of patients may experience an infection.1,2 The TYRX Absorbable Antibacterial Envelope is a mesh envelope that stabilizes the implantable device. It combats infection by releasing antimicrobial agents for seven days after the device is implanted.3 Studies have shown the TYRX envelope reduced the incidence of major infection by 40 percent in patients receiving cardiac implantable electronic devices (CIEDs), compared to the current standard of care, which is to give the patient pre-operative antibiotics.4 The envelope is fully absorbed by the body in approximately nine weeks.3,5

“There is strong evidence the TYRX envelope can help prevent major infection without increasing complications,” said Rob Kowal, M.D., vice president and chief medical officer of the Cardiac Rhythm and Heart Failure division at Medtronic. “That is a fundamental tenet of the Medtronic Mission, to alleviate pain, restore health and extend life. We’re proud of this recognition from the Cleveland Clinic.”

This is the 14th year the Cleveland Clinic has recognized 10 “state-of-the-art medical inventions” that its panel members believe will have the greatest impact on patient care. “Healthcare is ever-changing and we anticipate that these innovations will significantly transform the medical field and improve care for patients at Cleveland Clinic and throughout the world,” said Michael Roizen, M.D., Emeritus Chief Wellness Officer at Cleveland Clinic, who leads the panel.

The TYRX envelope is the latest Medtronic innovation to make the Cleveland Clinic list. The Medtronic MiniMed™ 670G system, a hybrid closed-loop insulin delivery system, topped the list in 2018. Leadless pacing of the heart, and technologies to treat stroke and high blood pressure have also made the list in recent years.

REFERENCES

1 Tarakji KG, et al. Am Heart J. 2016;180:12

2 Data on file for aggregated infection rate.

3 Huntingdon Life Sciences Study TR-2013-001.

4 Tarakji KG, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. NEJM. DOI: 10.1056/NEJMoa1901111

5 Sinclair Labs Study D13599.

IMPORTANT SAFETY INFORMATION

The TYRX Absorbable Antibacterial Envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body.

The TYRX Absorbable Antibacterial Envelope contains the antimicrobial agents Minocycline and Rifampin, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator.

The TYRX Absorbable Antibacterial Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, Rifampin, or absorbable sutures. The TYRX Absorbable Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE).

The use of this product in patients with compromised hepatic and renal function, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully, because Minocycline and Rifampin can cause additional stress on the hepatic and renal systems. Patients who receive the TYRX Absorbable Antibacterial Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.

L001-10282019