Contego Medical, Inc.

The Liberant platform is also compatible with Contego Medical’s Excipio thrombectomy hardware, which Medtronic partnered with last January. \n Medtronic reported that its new thrombectomy system, aimed at removing blood clots from the arms and legs, has begun its commercial rollout with its first procedures. At the same time, the medtech giant also made advances with a surgical tool for serious brain bleeds The Liberant aspiration catheters are designed to snake into blocked peripheral arteries and veins and remove wall-to-wall clots. It also employs ultrasonic sensors to measure blood flow, plus an algorithm that varies the aspiration power to minimize the patient\'s blood loss.“We’re able to remove clot burden with greater precision and, for patients, this means a procedure designed to be more efficient and aimed at helping them restore circulation and mobility as safely and effectively as possible,\" said Ajit Rao, M.D., director of vascular surgery research at Mount Sinai Hospital, who performed the device\'s first clinical procedure in late November.   The Liberant platform is also compatible with Contego Medical’s Excipio thrombectomy hardware, which Medtronic partnered with last January. That team-up included access to Contego’s FDA-approved Neuroguard IEP system combining a stent, post-dilation balloon and integrated embolic protection filter for carotid artery procedures.The deal also included an option for Medtronic to buy the Raleigh, North Carolina-based Contego. Meanwhile, Medtronic is currently in the process of spinning off its lucrative diabetes business to focus on its broader cardiovascular division.Separately, Medtronic also announced a new added indication for its long-running Onyx liquid embolic system, which forms a solid mass after being injected into the bloodstream, to help seal off the flow to dangerous malformations in the brain\'s blood vessels. The FDA granted a new approval for its use during surgeries to treat subdural hematomas, including chronic and subacute cases, through the blocking of the middle meningeal artery. Onyx was first approved by the FDA in 2005.   In a 2024 study, the system demonstrated drops in recurrence and re-operations by about 63%. Additionally, no Onyx-related complications were reported in the first six months after the procedure, with no associated deaths.In November, Medtronic posted 5.5% organic revenue growth for the second quarter of its 2026 fiscal calendar, totaling an adjusted $8.81 billion. Those earning included a 9.3% gain in cardiovascular device sales, which the company called its strongest advance in more than a decade outside of the COVID-19 pandemic.

Delivering durable revenue growth with strong earnings power; strength in Pulsed Field Ablation, Pacing, Structural Heart, Diabetes, and Neuromodulation GALWAY, Ireland, Feb. 18, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT) today announced financial results for its third quarter (Q3) of fiscal year 2025 (FY25), which ended January 24, 2025. Key Highlights Continue Reading View PDF View PDF Medtronic plc Revenue of $8.3 billion increased 2.5% as reported and 4.1% organic GAAP diluted EPS of $1.01 increased 2%; non-GAAP diluted EPS of $1.39 increased 7% Company reiterates full year revenue and EPS guidance Cardiac Ablation Solutions revenue increased low-20s on strength of pulsed field ablation (PFA) products U.S. Centers for Medicare and Medicaid (CMS) announced coverage for Renal Denervation for the treatment of Hypertension expected to become final on or before October 11, 2025 Financial Results Medtronic reported Q3 worldwide revenue of $8.292 billion, an increase of 2.5% as reported and 4.1% on an organic basis. Organic revenue growth comparison excludes: Other revenue of $32 million in the current year and $53 million in the prior year; and Foreign currency translation of -$103 million on the remaining segments. As reported, Q3 GAAP net income and diluted earnings per share (EPS) were $1.294 billion and $1.01, respectively, representing a decrease of 2% and an increase of 2%, respectively. As detailed in the financial schedules included at the end of this release, Q3 non-GAAP net income and non-GAAP diluted EPS were $1.787 billion and $1.39, respectively, representing increases of 3% and 7%, respectively. "We delivered strong earnings this quarter, with significant improvements in both our gross margin and operating margin on the back of our ninth quarter in a row of mid-single digit organic revenue growth," said Geoff Martha, Medtronic chairman and chief executive officer. "We are starting to see the results from our long term investments in groundbreaking innovation, such as pulsed field ablation, to drive growth in some of the most attractive markets in MedTech." Cardiovascular Portfolio The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $3.037 billion increased 3.7% as reported and 5.0% organic, with mid-single digit increases in CRHF and SH&A, and a low-single digit increase in CPV, all on an organic basis. CRHF results included mid-single digit growth in Cardiac Rhythm Management, driven by low-double digit growth in Cardiac Pacing Therapies, including mid-20s growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions achieved low-20s growth on rapid adoption of the PulseSelect™ and Affera™ Sphere-9™ PFA systems SHA results driven by high-single digit Structural Heart growth, excluding congenital, on the continued strength of the Evolut™ FX+ TAVR system, and high-single digit growth in Cardiac Surgery CPV growth driven by high-single digit growth in balloons and mid-single digit growth in guide catheters and drug-coated balloons Recent U.S. FDA approval for additional pulsed field ablation manufacturing site in Galway; immediately boosts Affera™ supply Expanded U.S. presence in fast-growing carotid market with exclusive Contego Medical distribution agreement; includes recently FDA approved carotid stenting system and option to acquire; Contego Medical running clinical trial on next-generation transcarotid artery revascularization (TCAR) system Announced CMS opened a National Coverage Analysis (NCA) on Renal Denervation for the treatment of hypertension, with coverage expected to become final on or before October 11, 2025 Neuroscience Portfolio The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.458 billion increased 4.4% as reported and 5.2% organic, with a low-double digit increase in Neuromodulation, mid-single digit increase in CST, and low-single digit increase in Specialty Therapies, all on an organic basis. CST driven by high-single digit Neurosurgery growth on continued adoption of the AiBLE™ ecosystem of enabling technology; CST in the U.S. grew high-single digits, winning share Specialty Therapies results driven by mid-single digit growth in Pelvic Health on continued adoption of the InterStim X™ system; ENT grew low-single digits on strength in PTeye™ capital and disposables; Neurovascular, excluding China, grew mid-single digit with strength in flow diversion Neuromodulation above market performance driven by low-double digit Pain Stim growth, including high-teens U.S. growth, on the continued launch of the Inceptiv™ spinal cord stimulator; Brain Modulation grew mid-teens globally and mid-twenties in the U.S. on the continued launch of the Percept™ RC deep brain stimulator (DBS) with BrainSense™ technology Received CE Mark for BrainSense™ Adaptive Deep Brain Stimulation (aDBS), a real-time closed-loop system Medical Surgical Portfolio The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. Revenue of $2.072 billion decreased 1.9% as reported and decreased 0.4% organic, with flat organic result in SE and low-single digit organic decline in ACM. SE results were affected by ongoing stapling segment pressures and a transient change in U.S. distributor buying patterns, partially offset by high-single digit growth in Emerging Markets and high-single digit growth in Advanced Energy on continued adoption of LigaSure™ vessel sealing technology ACM performance included high-single digit declines in Nellcor™ blood oxygen management products on a 30% year-over-year market decline in U.S. respiratory-related hospitalizations in the quarter; this was partially offset by high-single digit growth in Perioperative Complications Diabetes Revenue of $694 million increased 8.4% as reported and 10.4% organic. U.S. revenue grew mid-single digits on the continued adoption of the MiniMed™ 780G automated insulin delivery (AID) system, with an increase in the MiniMed™ 780G installed base and strong CGM attachment rates International revenue grew low-double digits on increasing CGM attachment as users upgrade to the Simplera Sync™ sensor Guidance Medtronic today reiterated its revenue growth and EPS guidance for FY25. The company continues to expect FY25 organic revenue growth in the range of 4.75% to 5%. The organic revenue growth guidance excludes the impact of foreign currency and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth would be in the range of 3.4% to 3.8%. The company continues to expect FY25 diluted non-GAAP EPS in the range of $5.44 to $5.50. This includes an estimated -5% impact from foreign currency exchange based on recent rates. The company's guidance represents FY25 diluted non-GAAP EPS growth in the range of 4.6% to 5.8%. "EPS came in above the high end of our guidance range. We were pleased with the operational performance of the business this quarter, turning mid-single digit organic growth into leveraged earnings, highlighted by healthy gross margin improvement," said Gary Corona, Medtronic interim chief financial officer. "Looking ahead, our restored earnings power continues. We will accelerate both top and bottom line growth in Q4, resulting in high-single digit adjusted EPS growth in the back half of our fiscal year." Video Webcast Information Medtronic will host a video webcast today, February 18, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com, and this earnings release will be archived at news.medtronic.com. Within 24 hours of the webcast, a replay of the webcast and transcript of the company's prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com. Medtronic plans to report its FY25 fourth quarter results on Wednesday, May 21, 2025. For fiscal year 2026, Medtronic plans to report its first, second, third, and fourth quarter results on Tuesday, August 19, 2025, November 18, 2025, February 17, 2026, and Wednesday, May 20, 2026, respectively. Confirmation and additional details will be provided closer to the specific event. Financial Schedules and Earnings Presentation The third quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com. To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here. To view the third quarter earnings presentation, click here. 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 (NYSE: MDT), visit and follow on LinkedIn. FORWARD LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, changing global trade policies, general economic conditions, and other risks and uncertainties described in the company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "going to," "will," and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances. NON-GAAP FINANCIAL MEASURES This press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2024, and references to sequential changes are in comparison to the prior fiscal quarter. Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company's underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company's consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release. Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance. -end- SOURCE Medtronic plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LAS VEGAS, Nov. 1, 2023 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the third of four Late-Breaking Clinical Trial sessions at the VIVA23 conference, hosted at Wynn Las Vegas. VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning's 5 late-breaking clinical trial presentations. A Multicenter Trial Evaluation of the Neuroguard Carotid Artery Stent System With Integrated Embolic Protection: 30-Day and 1-year Outcomes of PERFORMANCE II Presented by: William A. Gray, MD The PERFORMANCE II study is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Neuroguard IEP 3-in-1 carotid stent and postdilation balloon system with integrated embolic protection (Contego Medical, Inc.) for the treatment of carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy. A total of 305 patients were enrolled at 40 sites in the United States and Europe. The study's primary endpoint is the 30-day rate of major adverse events, defined as death, all stroke, and myocardial infarction within 30 days of the index procedure, plus ipsilateral stroke between day 31 and 1 year. Events were adjudicated by an independent clinical events committee, and angiograms and duplex ultrasounds were evaluated by an independent core lab. Of the 305 patients enrolled, the mean age was 70, and 20% were symptomatic. 230 (75%) patients had physiologic high-risk criteria, and 75 (25%) patients had anatomic high-risk criteria. The mean baseline angiographic stenosis was 85%, and 34% of lesions were severely calcified. At 30 days, the all-stroke rate was 1.31% (4 patients) and 0.98% (3 patients) in an intention-to-treat and per-protocol analysis, respectively. There were no major strokes, no contralateral strokes, one (0.3%) death (cardiovascular), and two (0.7%) non–ST-segment elevation myocardial infarctions through 30-day follow-up. Among asymptomatic patients, the 30-day stroke rate was 0.81% (2 patients). There was one (0.37%) minor ipsilateral stroke between day 31 and 1 year. There were no major strokes and no neurological deaths at 1 year. Target lesion revascularization through 1 year was 1.47% (4 patients). These 1-year outcomes of the PERFORMANCE II study demonstrate the safety and durability of the Neuroguard carotid stent system in a high-surgical-risk patient population and are the lowest event rates ever reported in an adequately powered, multicenter trial of any type of carotid revascularization, regardless of patient risk. Acute Clinical and 90-Day Functional Outcomes in Pulmonary Embolism Patients Treated With Computer Assisted Vacuum Thrombectomy: Interim Analysis of the STRIKE-PE Study Presented by: Ido Weinberg, MD The STRIKE-PE study is evaluating real-world safety, performance, and long-term quality-of-life outcomes of computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra, Inc.) for the treatment of pulmonary embolism (PE). This prospective, international, multicenter study will enroll 600 patients with acute PE symptoms of ≤ 14 days and a right ventricular/left ventricular (RV/LV) ratio ≥ 0.9. Primary endpoints are the change in RV/LV ratio from baseline to 48 hours postprocedure and the incidence of major adverse events (MAEs) at 48 hours. Secondary endpoints include functional outcome measures. We report acute clinical and 90-day functional outcomes from an interim analysis. This interim analysis included 150 patients (mean age, 61.3 years; 54.7% male; 5.3% with high-risk PE; 94.7% with intermediate-risk PE). Patients presented with high thrombus burden (modified Miller score ≥ 12) in 80.7% of cases. Mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours postthrombectomy (∆ 25.7%; P < .0001). Four (2.7%) patients experienced an MAE(s) within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased (P < .0001). Borg dyspnea scale significantly improved from presentation to discharge and from presentation to 90-day follow-up (P < .0001). The 6-minute walk test distance significantly improved from discharge to 90-day follow-up (P < .0001). At 90-day follow-up, the New York Heart Association class proportion distribution was similar to that reported before the acute PE episode (P = .39). STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety. At 90-day follow-up, treatment with CAVT with the Indigo aspiration system improved patients' functional capacity by reducing dyspnea, increasing aerobic endurance, and improving cardiac symptoms. 30-Day Results From the C-Guardians Pivotal Trial of the CGuard™ Carotid Stent System Presented by: D. Christopher Metzger, MD C-GUARDIANS is a pivotal FDA investigational device exemption trial designed to evaluate safety and efficacy of the neuroprotective CGuard carotid stent (InspireMD, Inc.) in treating symptomatic and asymptomatic patients with carotid stenosis at a high risk for carotid endarterectomy (CEA). From July 2021 to June 2023, 316 patients (mean age, 69.0 years; 31.6% female; 25% symptomatic) were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the United States and the European Union. Procedures were performed utilizing the CGuard self-expanding stent, incorporating its patented woven Micronet mesh sleeve with small pore size of 150 µm designed to prevent plaque protrusion, utilizing approved embolic protection systems intraprocedurally. The primary endpoint is a composite of (1) incidence of major adverse events including death (all-cause mortality), any stroke, and myocardial infarction (DSMI) through 30 days post–index procedure and (2) ipsilateral stroke from day 31 to day 365 postprocedure. All events were adjudicated by a clinical events committee. Intraprocedural cerebral protection utilized approved distal embolic filters or proximal embolic protection with flow cessation, or both. At 30 days, total major adverse events included a cumulative DSMI of 0.95% and a cumulative stroke and death rate of 0.95% (intent to treat, 0.95%; per protocol, 0.63%). Events included an in-hospital retinal stroke and a clinically silent troponin elevation, with two additional strokes at 30 days, including a patient who did not take dual antiplatelet therapy (protocol violation). In the C-GUARDIANS pivotal trial, stenting with the CGuard carotid stent system in patients with obstructive carotid artery disease and at high risk for CEA had an overall stroke and death rate of 0.95% from the postprocedural interval to 30-day follow-up. The results support a potential "neuroprotective" effect of the CGuard stent from the procedure to 30-day follow-up. Stellarex Vascular E-Registry (SAVER) Gender Subgroup Analysis Presented by: Marianne Brodmann, MD The Stellarex Vascular E-Registry (SAVER) was a multicenter, international, prospective registry designed to assess the safety and efficacy of the Stellarex drug-coated balloon (DCB; Philips) in femoral, popliteal, and/or infrapopliteal arteries in a broad, real-world, claudicant or critical limb ischemia patient population. Patients with Rutherford clinical classification 2 to 6 who were indicated for percutaneous transluminal angioplasty were enrolled. The study was conducted with an individual DCB under normal clinical practice. The primary safety outcome was freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization (CD-TLR) through 12 months. The primary efficacy outcome was freedom from CD-TLR at 12 months. Final 12-month outcomes of the above-the-knee (ATK) cohort were evaluated, and a subgroup analysis was performed to assess differences in outcomes according to gender. The SAVER ATK study demonstrated excellent key safety and efficacy endpoints at 12 months in a real-world population. There were no differences in outcomes when stratified into gender subgroups, demonstrating the strong safety and performance of the Stellarex DCB in both male and female patients. Clinical Outcomes of Sirolimus-Coated Balloons Compared With Standard Balloon Angioplasty for Patients With Chronic Limb-Threatening Ischemia Presented by: Edward Choke, MBBS, PhD Sirolimus-coated balloons (SCBs) are a potential treatment option to improve outcomes for chronic limb-threatening ischemia (CLTI). However, clinical data for this novel treatment for CLTI are lacking. This study aimed to investigate the clinical outcomes of MagicTouch percutaneous transluminal angioplasty (PTA) SCB (Concept Medical, Inc.) compared to plain old balloon angioplasty (POBA) for patients with CLTI. The HOPE registry is a single-center prospective registry of all CLTI patients. Prospective data captured included preprocedure baseline demographics, angioplasty details, and postprocedure clinical outcomes. Consecutive CLTI patients (n = 347) with Rutherford 4, 5, or 6 presentations and de novo infrainguinal artery disease between August 2018 and October 2021 were analyzed. Patients were excluded if they received paclitaxel devices, thrombolysis, or atherectomy devices. Patients were divided into two groups according to whether they received an SCB in addition to POBA (n = 141) or POBA alone (n = 206). There were no statistically significant differences in the baseline demographics and lesion characteristics between the SCB and POBA groups. At 2 years, SCBs were associated with statistically significant higher freedom from clinically driven target lesion revascularization (75.2% vs 66.2%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.97; P = .037), higher amputation-free survival (69.5% vs 55.1%; HR, 0.64; 95% CI, 0.46-0.88; P = .007), and higher survival (72.9% vs 64.3%; HR, 0.71; 95% CI, 0.50-0.99; P = .047). At 2 years, SCBs were also numerically but not statistically significantly associated with higher freedom from major amputation (93.5% vs 87.1%; HR, 0.63; 95% CI, 0.27-1.45; P = .274). Compared to POBA alone, use of SCBs was associated with improved clinical outcomes at 2 years, and no early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCBs for treatment of CLTI. About the VIVA Foundation The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about the VIVA Foundation, visit . SOURCE The VIVA Foundation