Financial Data and Key Metrics Changes - For the full year 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing in future growth [5][17] - Total adjusted revenues for Q4 2025 were $118.3 million, up 18.5% compared to Q4 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [16][17] - Adjusted EBITDA margin was 19.2% in Q4 2025, an improvement of approximately 110 basis points over the prior year [17] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 2025, driven by AMDS in the U.S. and strong international growth [6][20] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year, while BioGlue revenues were flat compared to the same period last year [8][20] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 2024 [21] - Gross margins were 63% in both 2025 and 2024, with the 2024 margin negatively impacted by an idle plant charge due to a cybersecurity incident [21] Company Strategy and Development Direction - The company plans to replicate its strategy by introducing additional stent graft products from Europe to the U.S. and Japan, aiming to expand its total addressable market [7] - Key growth drivers include AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [33][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth strategies, anticipating continued double-digit revenue growth and EBITDA margin expansion [14][28] - The company expects constant currency growth between 10%-14% for the full year 2026, with specific growth rates for different product lines [25][27] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [18][19] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [24] Q&A Session Summary Question: Impact of Italian clawback on growth - Management clarified that the Italian payback was specific to the EMEA line and did not impact major product lines [39] Question: Sell-in versus sell-through for AMDS - Management noted that implantations are continuing to grow and emphasized the importance of positive first experiences for surgeons [42] Question: Progress on AMDS target accounts - Management indicated that they are in the early stages of account openings and expect significant growth in 2026 [46] Question: Market opportunity for NEXUS - Management described the NEXUS market as nascent, with a U.S. market opportunity of $150 million, and expressed confidence in gaining market share [50] Question: Pricing for AMDS and NEXUS - Management affirmed that the pricing assumptions for AMDS and NEXUS remain appropriate due to favorable reimbursement conditions [56] Question: CapEx plans for 2026 - Management indicated that the increased CapEx is primarily for capacity expansion for On-X and internal IT investments [75]

Financial Data and Key Metrics Changes - For the full year of 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing significantly in future growth [5][15] - Total adjusted revenues for Q4 of 2025 were $118.3 million, up 18.5% compared to Q4 of 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [15][16] - Adjusted EBITDA margin was 19.2% in Q4 of 2025, an improvement of approximately 110 basis points over the prior year [16] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 compared to the same period last year, driven by AMDS in the U.S. and strong international growth [6][19] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year on a constant currency basis, while BioGlue revenues were flat compared to the same period last year [8][19] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 of 2024 [20] - Q4 gross margins were 63% in both 2025 and 2024, with the 2024 gross margin negatively impacted by an idle plant charge due to a cybersecurity incident [20] Company Strategy and Development Direction - The company plans to replicate its proven strategy by introducing additional stent graft products already generating revenue in Europe to the U.S. and Japan, aiming to expand the total addressable market [7] - Future growth is expected to be driven by AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion, with expectations for constant currency growth between 10%-14% for 2026 [23][26] - The company anticipates challenges in the second and third quarters of 2026 due to tougher comparisons and recovery of the tissue backlog [25] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [17][18] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [22] Q&A Session Summary Question: Impact of Italian clawback on growth - The Italian clawback was specific to the EMEA line and did not impact major product lines, thus not skewing growth rates [36][38] Question: Commentary on AMDS sell-in versus sell-through - Management does not typically break out details on AMDS revenue but noted that implantations are continuing to grow positively [40][41] Question: Progress on AMDS target accounts - The company is in the early stages of AMDS rollout, with significant opportunities to open new accounts and increase implants in existing accounts in 2026 [44][45] Question: Market opportunity for NEXUS - The NEXUS device is positioned in a nascent market with a $150 million U.S. opportunity, and the company believes it is well-positioned against competitors [46][48] Question: Pricing for AMDS and NEXUS - The company sees strong demand for AMDS and NEXUS at their current price points, supported by favorable reimbursement dynamics [54] Question: CapEx plans for 2026 - CapEx is expected to be approximately $50 million in 2026, primarily for capacity expansion and IT system improvements [71][72]

Financial Data and Key Metrics Changes - For the full year of 2025, total adjusted constant currency revenue growth was 13% and Adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow for the year [4][12] - Total adjusted revenues for Q4 2025 were $118.3 million, up 18.5% compared to Q4 2024, while adjusted EBITDA increased approximately 29% from $17.6 million to $22.7 million [12][13] - Adjusted EBITDA margin was 19.2% in Q4 2025, an improvement of approximately 110 basis points over the prior year [13] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 2025 compared to the same period last year, driven by AMDS in the U.S. and strong international growth [5][16] - On-X revenues grew 24% year-over-year on a constant currency basis in Q4 2025, supported by global market share gains and new U.S. market opportunities [6][16] - Tissue processing revenue increased 6% year-over-year on a constant currency basis in Q4 2025, while BioGlue revenues were flat compared to the same period last year [7][16] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 2024 [17] - Gross margins were 63% in both 2025 and 2024, with the 2024 gross margin negatively impacted by an idle plant charge due to a cybersecurity incident [17] Company Strategy and Development Direction - The company aims to replicate its successful strategy by introducing additional stent graft products generating revenue in Europe to the U.S. and Japan, which is expected to expand the total addressable market [5] - Key growth drivers include the commercialization of AMDS in the U.S., leveraging new clinical data for On-X heart valves, and advancing the NEXUS PMA [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion, with expectations for constant currency growth between 10%-14% for 2026 [20][24] - The company anticipates challenges in the AMDS launch due to tougher year-over-year comparisons but remains optimistic about growth opportunities [22][41] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [14][15] - Free cash flow for the full year was approximately $1 million, despite significant investments in business expansion [19] Q&A Session Summary Question: Impact of Italian clawback on growth - Management clarified that the Italian payback impacted the EMEA line and did not skew the growth rates of major product lines [32][34] Question: Sell-in versus sell-through for AMDS - Management indicated that while specific revenue details are not disclosed, implantations are growing well, and the first experiences for surgeons have been positive [36][41] Question: Market opportunity for NEXUS - Management described the NEXUS market as nascent, with a U.S. market opportunity of $150 million, and emphasized the unique technology's potential to gain market share [42][44] Question: Pricing strategy for AMDS and NEXUS - Management confirmed that the pricing levels for AMDS and NEXUS are seen as appropriate, with favorable reimbursement dynamics supporting demand [51] Question: CapEx plans for 2026 - Management indicated that the $50 million CapEx for 2026 is primarily for capacity expansion for On-X and internal IT investments [68]

Summary of Artivion Conference Call Company Overview - **Company**: Artivion - **Industry**: Medical Devices, specifically focusing on aortic technologies Key Points and Arguments Strategic Focus and Vision - Artivion has shifted its focus to cardiac and vascular surgeons treating the aorta, divesting non-aortic products to concentrate on unmet clinical needs in this area [2][3][5] - The company has made several strategic acquisitions over the past five years, including On-X, Jotec, and Ascyrus, to enhance its product offerings and address significant clinical challenges [3][5][6] Product Pipeline and Growth - Artivion has a robust pipeline with seven PMAs (Premarket Approvals) in progress, indicating a strong future growth trajectory without the immediate need for further acquisitions [9][10] - The company anticipates double-digit revenue growth and EBITDA growth at twice the rate of revenue for many years, with recent quarters showing even higher growth rates [15][17][40] AMDS Technology - The AMDS (Aortic Malperfusion Device System) is expected to expand the market for treating acute type A aortic dissections, potentially reducing mortality rates significantly [18][20] - AMDS is positioned to be used in a wider range of centers, which could lead to increased adoption and market expansion [18][20][21] Competitive Landscape - AMDS competes with existing technologies like the Frozen Elephant Trunk and hemianchor repair, but its ease of use and effectiveness may lead to broader adoption among surgeons [21][23] - The company aims to maintain a comprehensive aortic strategy by offering multiple treatment options, ensuring they meet diverse patient needs [23][24] Financial Performance and Projections - The mechanical heart valve business, particularly On-X, has seen significant growth, with recent quarters showing over 20% growth, driven by new clinical data demonstrating advantages over bioprosthetic valves [28][30][31] - The company expects gross margins to improve, with a target of reaching 70% in the long term, driven by the introduction of high-margin products [42][45] Operational and Financial Management - Artivion is focused on maintaining operational scalability to support growth, ensuring that infrastructure keeps pace with increasing demand for high-margin products [49][50] - The company has a solid cash flow management strategy, with priorities including funding for potential acquisitions and debt repayment [57] Market Dynamics and Reimbursement - The introduction of a new DRG (Diagnosis-Related Group) for complex aortic arch procedures is expected to facilitate AMDS adoption by improving reimbursement rates [27] - The company has successfully navigated previous reimbursement challenges, and the new DRG is seen as a positive development for market entry [27] Future Outlook - Artivion is optimistic about its growth prospects, with plans to train surgeons on AMDS and leverage new clinical data to drive market share [33][36] - The company is committed to a long-term growth strategy, focusing on innovation and customer needs in the aortic space [60][61] Additional Important Insights - The company has experienced a significant shift in its market positioning and is now seen as a leader in aortic technologies, with a clear focus on addressing critical clinical needs [1][2][60] - Artivion's management emphasizes the importance of aligning all teams towards a common goal of delivering innovative aortic solutions to improve patient outcomes [60][61]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $113.4 million, representing a 16% increase compared to Q3 2024 [15] - Adjusted EBITDA increased approximately 39% from $17.7 million to $24.6 million in Q3 2025 [15] - Adjusted EBITDA margin improved to 21.7%, a 320 basis point increase year-over-year [16] - Gross margins were 65.6% in Q3 2025, up from 63.7% in Q3 2024, reflecting a 200 basis point increase [17] Business Line Data and Key Metrics Changes - Stent Graft revenues grew 31% on a constant currency basis in Q3 2025 [16] - ON-X revenues increased by 23% year-over-year on a constant currency basis [16] - Tissue processing revenue rose 5% year-over-year on a constant currency basis [11] - BioGlue revenues grew 1% in Q3 compared to the same period last year [11] Market Data and Key Metrics Changes - Revenues in North America increased by 19% [16] - Asia-Pacific revenues grew by 18% [16] - EMEA revenues increased by 12% [16] - Latin America revenues rose by 10% [16] Company Strategy and Development Direction - The company aims to replicate its successful Stent Graft strategy in the U.S. and Japan, expanding its total addressable market [5] - The establishment of a new MS-DRG code for complex aortic procedures is expected to enhance the economic value proposition of AMDS [7] - The company is focused on advancing a robust pipeline of high-margin innovations, estimating a $1 billion incremental market opportunity over the next five-plus years [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth while growing adjusted EBITDA at twice the rate of revenue growth [15] - The company anticipates continued growth driven by AMDS, On-X heart valves, and the Nexus PMA [24] - Management highlighted the importance of new clinical data and reimbursement dynamics as tailwinds for growth [24] Other Important Information - The company expects to be slightly cash flow negative for the full year 2025 due to a one-time cash payment related to facility purchases [18] - As of September 30, 2025, the company had approximately $73.4 million in cash and $214.9 million in debt [19] Q&A Session Summary Question: What is the expected annualized cost for the Arcevo trial? - Management indicated that R&D funding is expected to be 7%-8% of sales annually, with a full year of trial costs anticipated in 2026 [27] Question: What is driving the growth of ON-X? - Management noted that growth is attributed to market share gains and new clinical data showing benefits of mechanical valves over bioprosthetic valves [29] Question: Can you elaborate on the new DRG and its economic implications? - Management explained that the new DRG reflects the high cost and complexity of advanced aortic arch procedures, which should alleviate previous economic challenges [31] Question: What is the expected market size for Arcevo? - The estimated market size for the frozen elephant trunk in the U.S. is about $80 million [38] Question: How is AMDS performing in terms of sell-through versus sell-in? - Management stated that revenue is currently weighted towards initial stocking, with increasing implantations expected [35] Question: What are the expectations for AMDS in international markets? - The company plans to pursue PMA approval in the U.S. before moving towards approvals in Japan and China [42]

Core Insights - Artivion (NYSE:AORT) exceeded Wall Street's revenue expectations for Q3 CY2025, reporting sales of $113.4 million, which represents an 18.4% year-on-year growth and a 2.6% beat against analyst estimates [1][7] - The company raised its full-year revenue guidance to $442 million at the midpoint, slightly above analysts' expectations [1][7] - Non-GAAP profit per share was reported at $0.16, aligning with consensus estimates [1][7] Revenue Growth - Artivion achieved a 16% constant currency revenue growth in Q3, driven by significant year-over-year increases in stent grafts (38%), On-X (25%), preservation services (5%), and BioGlue (2%) compared to Q3 2024 [3] - The company has demonstrated a 10.6% annualized revenue growth over the last five years, which is slightly above the average for healthcare companies, indicating strong customer resonance [5] - Over the last two years, Artivion's annualized revenue growth was 11.5%, consistent with its five-year trend, suggesting stable demand [6] Financial Performance - Adjusted EBITDA for Q3 was $24.57 million, exceeding analyst estimates of $22.25 million, with a margin of 21.7% [7] - Operating margin improved to 11.1%, up from 4.6% in the same quarter last year, while free cash flow margin increased to 15.6%, up from 8.2% year-on-year [7] - Market capitalization stands at $2.19 billion [7]

Investment Activity - Oppenheimer Asset Management Inc. purchased 21,513 shares of Artivion, Inc. valued at approximately $669,000, representing about 0.05% ownership at the end of the last quarter [2] - MCF Advisors LLC increased its holdings by 109.3%, now owning 1,176 shares worth $29,000 after buying an additional 614 shares [2] - Other institutional investors, including EntryPoint Capital LLC, Natixis Advisors LLC, and Zurcher Kantonalbank Zurich Cantonalbank, also increased their stakes in Artivion during the first quarter [2] Analyst Ratings - Citigroup maintained an "outperform" rating for Artivion [3] - Needham & Company raised the price target from $45.00 to $50.00 and assigned a "buy" rating [3] - The average rating for Artivion is "Moderate Buy" with a consensus target price of $43.97 [3] Stock Performance - Artivion's stock opened at $45.41, with a 52-week low of $21.97 and a high of $46.19 [4] - The company has a market capitalization of $2.14 billion and a PE ratio of -108.12 [4] Financial Results - Artivion reported $0.24 EPS for the last quarter, exceeding estimates of $0.11 by $0.13 [5] - Revenue for the quarter was $112.97 million, up 15.3% year-over-year, surpassing estimates of $107.96 million [5] - The company has set its FY 2025 guidance at EPS, with analysts forecasting $0.37 for the current fiscal year [5] Insider Transactions - SVP Jean F. Holloway sold 23,356 shares at an average price of $43.01, totaling approximately $1,004,541.56, reducing ownership by 11.95% [6] - SVP Marshall S. Stanton sold 18,200 shares at an average price of $44.02, totaling approximately $801,164.00, representing a 22.09% decrease in position [6] - Insiders have sold a total of 74,858 shares worth $3,250,129 over the last three months, with insiders owning 7.60% of the stock [6] Company Overview - Artivion, Inc. manufactures and distributes medical devices and implantable human tissues, including BioGlue and aortic arch stent grafts [8]

Summary of Artivion (NYSE:AORT) FY Conference Call - September 10, 2025 Company Overview - Artivion is focused on aorta-related medical devices, particularly heart valves for patients under 65 years old, and products for treating aortic aneurysms and dissections [4][5] - The company has a revenue guidance midpoint of $440 million for the year, with a 20% EBITDA margin [4] - Artivion aims for double-digit growth in sales and to grow EBITDA at twice the rate of sales [4][6] Financial Performance and Guidance - The company expects an acceleration in growth in the second half of 2025, driven by the launch of AMDS and easier comparisons due to a cyber attack in the previous year [6][7] - Historical EBITDA margin expansion of 200 to 300 basis points annually, with expectations for continued leverage in sales and marketing [7][8] - Current gross margin is approximately 65%, with AMDS expected to contribute significantly higher margins [8] Product Portfolio and Growth Drivers - The On-X mechanical valve business has seen durable growth, with a 22% increase worldwide, driven by positive clinical data and cross-selling opportunities [9][12] - AMDS is a new device for treating acute type A aortic dissection, showing promising clinical trial results with a mortality rate of 9.7% compared to a historical rate of 35% [16][14] - The Arsivo product, a third-generation frozen elephant trunk device, is set to begin trials, with expectations for FDA approval and expansion into the U.S. and Japan [23][24] Market Position and Competitive Advantage - Artivion emphasizes its focus on the aorta, with a pipeline of PMA-protected products and a strong market position [38][39] - The company has a competitive advantage in its technologies, with few competitors in each segment and high barriers to entry due to PMA requirements [41][42] - The company is confident in its ability to maintain and grow its market share, particularly with differentiated products [39][40] International Strategy and Market Expansion - Currently, Artivion's revenue is split 50-50 between international and U.S. markets, with plans to maximize U.S. growth while continuing to expand internationally [50][53] - The company has invested significantly in Asia and Latin America, with expectations for continued double-digit growth in international markets [51][54] Capital Allocation and Future Outlook - Artivion plans to allocate capital towards acquiring Endospan and paying down debt, with no immediate plans for share repurchases [35][36] - The company has a robust R&D pipeline with five PMAs in development, indicating a long-term growth trajectory [56][57] Key Takeaways - Artivion is positioned as a unique player in the aorta-focused medical device market, with strong financial health and growth potential [56][57] - The company’s focus on innovation and differentiation in its product offerings is expected to sustain its competitive edge and drive future growth [38][39]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $113 million, representing a year-over-year increase of over 14% compared to 2024 [17] - Adjusted EBITDA grew approximately 33% from $18.6 million to $24.8 million in Q2 2025 [17] - Adjusted EBITDA margin improved to 21.9%, reflecting a 300 basis point increase from the prior year [18] - Gross margins were 64.7% in Q2 2025, slightly up from 64.6% in 2024 [19] Business Line Data and Key Metrics Changes - On X revenue increased by 24% year-over-year on a constant currency basis [5] - Stent graft revenues grew by 22% on a constant currency basis [6] - BioGlue revenue grew by 4% year-over-year [10] - Tissue processing revenues increased by 3% year-over-year [10] Market Data and Key Metrics Changes - Revenues in North America increased by 18%, Asia Pacific by 15%, EMEA by 10%, and Latin America by 7%, all compared to 2024 [18] Company Strategy and Development Direction - The company is focused on expanding its addressable market through ongoing product launches, particularly the AMDS following FDA approval [4][12] - The strategy includes leveraging cross-selling opportunities and enhancing the product portfolio to drive growth [6][26] - The company aims to deliver sustainable double-digit revenue growth and drive EBITDA margin expansion [15][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and expanding EBITDA margins, driven by strong product performance and market opportunities [15][26] - The company anticipates a full-year revenue growth rate of 12% to 14% for 2025, raising the midpoint of its guidance [22][23] - Management highlighted the positive reception of the AMDS launch and the potential for significant market opportunities [10][12] Other Important Information - The company successfully reduced its net leverage ratio from 4.1 to 2.2 by retiring convertible debt [21][22] - Free cash flow for Q2 2025 was $11.7 million, with expectations to remain positive for the full year [21][86] Q&A Session Summary Question: Update on AMDS and hospital adoption - Management noted that there are about 1,000 accounts capable of performing AMDS procedures, with ongoing training sessions leading to increased cross-selling opportunities [35][36] Question: BioGlue launch in China - Management indicated that BioGlue is expected to launch in the second half of 2025, with ongoing preparations [40] Question: Guidance dynamics and currency impact - Management explained that the guidance was adjusted due to strong Q2 performance and favorable currency movements, leading to an increase in revenue expectations [42][43] Question: Physician adoption of AMDS - Management reported positive feedback from physicians, noting that the device is simple to use and has been quickly integrated into practices [47][49] Question: Future expansion of the commercial team - Management stated that while they are evaluating expansion, the focus remains on the top 600 centers for the AMDS launch [54] Question: Next steps for Arecibo trial - Management confirmed that they expect to enroll the first patient in the Arecibo trial by the end of the year, pending hospital contracts and IRB approvals [57] Question: Pricing trends - Management indicated that there has been no significant price pressure, with modest inflationary price increases continuing [79] Question: Contribution of On X growth from cross-selling - Management acknowledged a meaningful uptick from new accounts, attributing growth to both cross-selling and new data [84]

Financial Performance and Guidance - Artivion reported approximately $400 million in revenue and around $70 million in EBITDA for FY24[4] - The company projects revenue between $423 million and $435 million for 2025, representing constant currency revenue growth of 11%-14% compared to 2024[3] - Artivion anticipates Adjusted EBITDA between $84 million and $91 million in 2025, a growth of 18-28% over 2024[3] - The company expects net debt leverage to decrease to below 20x by the end of 2025[3] Market Opportunities and Growth Strategy - Artivion is focused on driving sustained double-digit revenue growth and 2x+ EBITDA growth[3, 13] - The company estimates a total addressable market of approximately $4 billion for E-vita OPEN NEO, AMDS, NEXUS, E-nside, Artivex and E-tegra, with market growth rates between mid-single and mid-teen digits[3] - Mechanical Heart Valves (On-X) hold the 2 position with 34% market share in a $250 million global market[16] - Preservation Services (CryoValve® SG) holds the 1 position with 65% market share in a $150 million global market[16] - Surgical Sealant (BioGlue) holds the 2 position with 28% market share in a $260 million global market[16] Clinical Trial Data and Product Development - AMDS PERSEVERE US IDE study data demonstrates a significant reduction in Major Adverse Events (MAEs) at 30 days compared to the hemiarch control group (269% vs 580%)[38] - Endospan NEXUS ® TRIOMPHE US IDE Trial 30-day data demonstrates a 63% reduction in major adverse event (MAE) rate compared to the reference performance goal (130% vs 350%, p<0001)[41] - On-X Aortic Heart Valve Post Approval Study (PAS) shows a 66% reduction in major events and an 87% reduction in major bleeding compared to the PROACT IDE study[19]