Medtronic receives CE Mark for Penditure™ Left Atrial Appendage (LAA) Exclusion System, ushering in a new era of left atrial appendage management in Europe as it surpasses[...]

Medtronic plc, a global leader in healthcare technology, today announced its Penditure™ Left Atrial Appendage (LAA) Exclusion System has officially received CE Mark approval and will be launched in Europe at the 39^th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting from October 8-11 in Copenhagen, Denmark. The Penditure device recently surpassed 10,000 clips sold globally.

The Penditure LAA Exclusion System is an innovative, implantable clip that comes pre-loaded on a single-use delivery system for use in left atrial appendage management (LAAM) during concomitant cardiac surgery procedures. The Penditure clip is curved to better match the atrial anatomy¹ and designed without fabric for reduced risk of inflammation.² The Penditure device is the only LAA clip on the market today that can be recaptured, repositioned, and redeployed after deployment during a procedure, putting more control in the hands of surgeons.³

A Commitment to Patients
"The strategic addition of the Penditure Left Atrial Appendage Exclusion System demonstrates our commitment to investing in cardiac surgeons and their growing needs for managing patients with more complex cardiac disease", said Giuseppe Savoja, Western Europe senior business director for the Cardiac Surgery business, which is part of the Cardiovascular Portfolio at Medtronic. "The Penditure device reinforces our commitment to innovation and provides an important, new, differentiated LAA management option for cardiac surgeons in the care of their patients in Western Europe. We are excited to officially launch the Penditure device in the European market and to feature it at our EACTS booth and Medtronic Training Center as well as during the October 9^th Medtronic Lunch Symposium for the first time."

As the only company serving the entire heart care team of cardiac surgeons and perfusionists, Medtronic offers the most robust Cardiac Surgery portfolio available today. Medtronic is committed to innovating in heart valves, surgical ablation, left atrial appendage management (LAAM), revascularization, perfusion, cannulation technologies, and ECMO therapies to advance treatment options, providing distinct benefits to physicians and clinicians, enabling them to focus on the holistic lifetime management of patients.

"Clinicians expect more from Medtronic and we are uniquely positioned to meet these needs to better serve their patients," said Pieter Kappetein, Ph.D., M.D., chief medical officer, Cardiac Surgery, Medtronic. "The Penditure LAA Exclusion System brings innovation to the space, with a wide opening at the base offering good visibility, which may assist in proper clip placement. Surgeons can place the Penditure LAA Exclusion System confidently while having the added benefit of recapturability after initial deployment if needed."

About Left Atrial Appendage Management
The American College of Cardiology (ACC) ⁴, American Heart Association (AHA)⁵, and Society of Thoracic Surgeons (STS) guidelines⁶ recommend that patients undergoing a concomitant cardiac surgery procedure and have pre-operative (pre-op) AF should have their LAA closed. This is because patients with atrial fibrillation (AF) experience a five times greater risk of stroke⁷, and most stroke-causing clots originate in the LAA.⁸ Closing the LAA may prevent these blood clots from entering the bloodstream. With CE Mark for the Penditure LAA Exclusion System, the company is now poised to redefine left atrial appendage management across Europe.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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¹ Product Specification Matrix PRS-00001 and Curvature report (EGS-00006)
² Syntheon's LAA Tissue testing. Reference EGS-00007 / GLP Animal Study TR-0023

³ Syntheon Product Specification Matrix (PRS-00001) and IFU (M050807C001B)
⁴ Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the american college of cardiology/american heart association joint committee on clinical practice guidelines. Circulation. 2021;143(5). doi:10.1161/cir.0000000000000923
⁵ January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the american college of cardiology/american heart association task force on clinical practice guidelines and the heart rhythm society in collaboration with the Society of Thoracic Surgeons. Circulation. 2019;140(2). doi:10.1161/cir.0000000000000665
⁶ Badhwar V, Rankin JS, Damiano RJ, et al. The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. January 2017;103(1):329-341
⁷ Win NT, Teo SP. Atrial fibrillation in older patients-reducing stroke risk is not only about anticoagulation. J Geriatr Cardiol. 2016;13(10):880-882. doi:10.11909/j.issn.1671-5411.2016.10.004
⁸ Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61(2):755-759. doi:10.1016/0003-4975(95)00887-X

Contacts:
María Trenzado
Communications
Medtronic Western Europe
+34 653 30 47 20

Becky Dvorak
Communications
Medtronic Cardiac Surgery
+1-612-309-7149

Ryan Weispfenning
Investor Relations
Medtronic
+1-763-505-4626