The Future of Cardiac Surgery: Meaningful Innovations to Serve Evolving Needs: When Clinician Feedback Drives Innovation, Patients Benefit

One of the most rewarding parts of my job is visiting clinicians. In the last year, I’ve spent time with cardiac surgeons and perfusionists across the globe seeing their operating rooms (OR) and touring new investments across their hospitals. My team and I received the opportunity to learn about new procedural techniques and see the challenges they face firsthand. These engagements are important as we seek to improve patient care around the world.

In our visits, we saw the complexity of cases becoming more common in surgical aortic valve replacement (SAVR). In listening to cardiac surgeons, we understand the importance of having a valve that is fit for the future, right from the start. Consistent with this understanding, Medtronic Cardiac Surgery recently announced the launch of the Avalus™ Ultra bioprosthesis.

Innovating on the Avalus™ valve’s long-term durability with a decade of clinical experience, and trusted performance to serve patients over their lifetime,ᶦ·ᶦᶦ·ᶦᶦᶦ the new Avalus Ultra valve was engineered to facilitate ease of use at implant,ᶦᵛ provide straightforward sizing for the right valve fit,ᵛ·ᵛᶦ and clear visibility for future valve-in-valve procedures. ᵛᶦᶦ·ᵛᶦᶦᶦ

These attributes come from both clinician feedback and thoughtful design. Through our internal testing and published literature, data suggest a circular, non-deformable based SAVR is beneficial for patient lifetime management, including durability and hemodynamics.ᶦˣ

Additionally, design characteristics like a non-deformable SAVR for circular landing zone and supra-annular TAVR can be helpful for valve-in-valve procedures.

We are firmly committed to designing valves fit for the future right from the start with a polymer base that is designed to maintain circularity for future potential TAVR intervention. ˣ·ˣᶦ Ensuring the circularity of a bioprosthetic aortic valve optimized the coaptation and potentially durability.

In addition to these design benefits, the Avalus Ultra valve is easy to place, has an industry leading Effective Orifice Area (EOA), is MRI conditional, and is clearly visible under fluoroscopy. It's designed with our amino oleic acid (AOATM) treatment, proven to be an innovative tissue treatment to reduce calcification in the tissue leaflet, used across Medtronic SAVR and TAVR platforms. ˣᶦᶦ·ˣᶦᶦᶦ·ˣᶦᵛ Our Avalus platform is the most studied contemporary stented surgical aortic valve, demonstrating our commitment to safety and effectiveness. ˣᵛ·ˣᵛᶦ·ˣᵛᶦᶦ·ˣᵛᶦᶦ·ᶦ·ˣᶦˣ·ˣˣ

Investing in and Innovating for Cardiac Surgery

The Avalus Ultra valve is one of several product launches this year, as we look to drive innovation internally and externally, and look for new opportunities to improve supply.

Earlier this year, we launched the Medtronic left atrial appendage (LAA) clip (Penditure™ LAA Exclusion System) our first solution in the LAA management market. And, we also made the strategic acquisition of the Grand Rapids, MI-based operations of Viant Medical. Viant Medical is a critical supplier of some 600 finished products for cardiac surgery, including our cannula and beating heart products.

Through these investments, we are innovating not only to deliver advanced technologies, but to identify durable supply solutions to help support cardiac surgical procedures globally. I’m proud that Medtronic offers the most robust cardiac surgery portfolio available today to support multiple cardiac surgical markets when they need it most.

I’d like to thank the cardiac surgeons who have shared insights, and allowed us to observe, listen and learn about new opportunities to advance patient care.

#Medtronic #CardiacSurgery #AvalusUltra #Innovation #PatientCare #SurgicalValve #HealthcareTechnology

[i] Klautz RJM, Dagenais F, Reardon MJ, Lange R, Moront MG, Labrousse L et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg 2022 Aug 3;62(3)

[ii] Klautz RJM, Rao V, Reardon MJ, et al. Hemodynamic function of contemporary surgical aortic valves 1 year postimplant. Abstract presented at: 37th Annual Meeting of the European Association for Cardio-Thoracic Surgery; October 4-7, 2023; Vienna, Austria.

[iii]Sohn SH, Kang Y, Kim JS, et al., A Randomized Trial Comparing One-year Hemodynamics of Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2023 Dec 5

[iv] Based on internal test report D00998354, Avalus Ultra HFE Design Validation Test Report.

[v] Avalus Ultra HFE Design Validation Test Report.

[vi] Based on internal document D00437207, Avalus Ultra Design Concept

[vii] Based on internal test report D00998354, Avalus Ultra HFE Design Validation Test Report.

[viii] Based on internal document D00437207, Avalus Ultra Design Concept

[ix] Klautz RJM, Rao V, Reardon MJ, et al. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. Published online May 6, 2024. 2. Klautz RJM, Rao V, Reardon MJ, et al. Hemodynamic function of contemporary surgical aortic valves 1 year postimplant. Paper presented at: 37th Annual Meeting of the European Association for Cardio-Thoracic Surgery; October 4–7, 2023; Vienna, Austria.

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[xii] Gott JP, Pan-Chih, Dorsey JM, et al. Calcification of porcine valves: a successful new method of antimineralization. Ann Thorac Surg. February 1992;53(2):207–215.

[xiii] Girardot MN, Girardot JM, Schoen FJ. Development of the AOA process as antimineralization treatment for bioprosthetic heart valves. Trans Soc Biomat. 1993;16:266.

[xiv] Girardot MN, Torrianni M, Girardot JM. Effect of AOA on glutaraldehyde-fixed bioprosthetic heart valve cusps and walls: Binding and calcification studies. Int J Artif Organs. February 1994;17(2):76–82.

[xv] Klautz RJM, Dagenais F, Reardon MJ, Lange R, Moront MG, Labrousse L et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg 2022 Aug 3;62(3).

[xvi] Klautz RJM, Rao V, Reardon MJ et al., Examining the Typical Hemodynamic Performance of Nearly 3000 1 Modern Surgical Aortic Bioprostheses. EurJCardiothoracSurg 2024 May 6:ezae122.

[xvii] Verbelen T, Roussel JC, Cathenis K, et al., Real-world data on the Avalus pericardial aortic valve: Initial results from a prospective, multi-center registry . Abstract Presented at HVS 2024.

[xviii] Sohn SH, Kang Y, Kim JS, et al., A Randomized Trial Comparing One-year Hemodynamics of Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2023 Dec 5.

[xix] Tadokoro N, Fukushima S, Shimahara Y, et al., Comparison of safety and haemodynamic performance between the Avalus stented aortic valve bioprosthesis and Magna valve in Japanese patients. General Thoracic and Cardiovascular Surgery (2021) 69:1060–1069.

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