A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

开始日期2024-11-01

申办/合作机构

Medtronic Vascular, Inc.

NCT06216769 / RecruitingN/AIIT

Comparison Between Continuous Oral Anticoagulation Versus Pill-in-the-POCKET Oral AntiCoagulation Strategy Guided by Continuous Rhythm Monitoring Using Implantable Loop Recorder After Atrial Fibrillation Catheter Ablation

The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.

开始日期2024-02-01

申办/合作机构

Seoul National University Hospital

[+2]

NCT06108973 / Not yet recruitingN/A

Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients Under General Anesthesia

All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of sevoflurane is compared with Chronic Obstructive Pulmonary Disease and Normal Patients .

开始日期2024-01-01

申办/合作机构

Medtronic Spine LLC

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472

项与 Medtronic, Inc. 相关的文献（医药）

2024-12-07·EUROPEAN HEART JOURNAL

Accelerated atrial pacing reduces left-heart filling pressure: a combined clinical-computational study

Article

作者: Prinzen, Frits ; van Empel, Vanessa ; Wolffs, Joey ; Cornelussen, Richard ; Lumens, Joost ; Delhaas, Tammo ; Rijks, Jesse ; van Osta, Nick ; Vernooy, Kevin ; van Koll, Johan ; Luermans, Justin ; van Loon, Tim ; Linz, Dominik

Abstract:

Background and Aims:

Accelerated atrial pacing offers potential benefits for patients with heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF), compared with standard lower-rate pacing. The study investigates the relationship between atrial pacing rate and left-heart filling pressure.

Methods:

Seventy-five consecutive patients undergoing catheter ablation for AF underwent assessment of mean left atrial pressure (mLAP) and atrioventricular (AV) conduction delay (PR interval) in sinus rhythm and accelerated atrial pacing with 10 bpm increments up to Wenckebach block. Computer simulations (CircAdapt) of a virtual HFpEF cohort complemented clinical observations and hypothesized the modulating effects of AV coupling and atrial (dys)function.

Results:

In the study cohort, 49(65%) patients had a high HFpEF likelihood (H2FPEF ≥ 5.0), and 28(37%) an elevated mLAP ≥ 15 mmHg at sinus rhythm. Optimal pacing rates of 100 [70–110]bpm (median [IQR]) significantly reduced mLAP from 12.8 [10.0–17.4]mmHg in sinus rhythm (55 [52–61]bpm) to 10.4 [7.8–14.8]mmHg (P < .001). Conversely, higher pacing rates (130 [110–140]bpm) significantly increased mLAP to 14.7 [11.0–17.8]mmHg (P < .05). PR interval and, hence, AV conduction delay prolonged incrementally with increasing pacing rates. Simulations corroborated these clinical findings, showing mLAP reduction at a moderately increased pacing rate and a subsequent increase at higher rates. Moreover, simulations suggested that mLAP reduction is optimized when AV conduction delay shortens with increasing rate.

Conclusions:

Accelerated pacing acutely reduces left-heart filling pressure in patients undergoing AF catheter ablation and computer simulations with HFpEF features, suggesting it as a potential therapeutic strategy to alleviate congestion symptoms. Virtual HFpEF patient cohorts hypothesize that AV sequential pacing may further optimize this therapy's beneficial effects.

2024-12-01·HYPERTENSION

Renal Denervation Lowers Nighttime Blood Pressure in True Resistant Hypertension

Letter

作者: Böhm, Michael ; Tsioufis, Konstantinos ; Schmieder, Roland E. ; Townsend, Raymond R. ; Weber, Michael A. ; Mahfoud, Felix ; Liu, Minglei ; Kario, Kazuomi ; Kandzari, David E.

2024-12-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Dynamic biomarker profiles in patients with paroxysmal atrial fibrillation: Assessing the differences between sinus rhythm and acute atrial fibrillation episode

Article

作者: van de Lande, Martijn E ; Rienstra, Michiel ; van Gelder, Isabelle C. ; Spronk, Henri M H ; Mulder, Bart A ; van Gelder, Isabelle C ; Crijns, Harry J.G.M. ; van de Lande, Martijn E. ; de Melis, Mirko ; ten Cate, Hugo ; Crijns, Harry J G M ; Velt, Marieke J.H. ; Ten Cate, Hugo ; Mulder, Bart A. ; Linz, Dominik ; Spronk, Henri ; Velt, Marieke J H

BACKGROUND:

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults, yet its underlying pathophysiology remains poorly understood. This study assessed whether circulating biomarker concentrations differ in paroxysmal AF patients during an acute episode compared to sinus rhythm.

METHODS:

The Time of Calamity study is a prospective biomarker study within the RACE V study. Patients underwent venous blood sampling in sinus rhythm at inclusion in RACE V, as well as during a subsequent acute episode of AF for which patients reported to the hospital. Ten biomarkers were analyzed.

RESULTS:

Thirty-nine patients (mean age 60 ± 9 years, 10 (25 %) women) were enrolled. During an acute AF episode, dickkopf-related protein 3 and insulin-like growth factor binding protein 7 were significantly lower, while N-terminal pro B-type natriuretic peptide (NT-proBNP), high-sensitive troponin T (hsTnT), growth differentiation factor 15, and interleukin 6 were significantly higher (all p < 0.05).

CONCLUSIONS:

Biomarker concentrations in paroxysmal AF patients are dynamic and differ between sinus rhythm and acute AF episodes. Notably, NT-proBNP and hsTnT, commonly used in clinical practice, were significantly elevated during an acute AF episode.

221

项与 Medtronic, Inc. 相关的新闻（医药）

2024-12-03

·PRNewswire

Okami Medical Appoints Bill Hoffman to its Board of Directors

ALISO VIEJO, Calif., Dec. 3, 2024 /PRNewswire/ -- Okami Medical, a commercial-stage medical device company, today announced the appointment of Bill Hoffman to its Board of Directors. "We are thrilled to welcome Bill to our Board of Directors," said Rhonda Robb, President and CEO of Okami Medical. "Bill brings extensive experience in the medical device industry and is an exceptionally strong leader with a track record of driving growth while creating a culture of operational excellence." Mr. Hoffman is a Venture Partner at Vensana Capital. He serves as a member of the board of directors for several med tech companies, including Inari Medical, where he held the CEO role from 2015 until 2022, leading the company through its initial public offering and helping to establish it as the global leader in the treatment of venous thromboembolism. He previously served as CEO at Visualase, acquired by Medtronic in 2014, and VP Sales at FoxHollow Technologies, acquired by ev3 in 2007. "I'm honored to join the Okami team and have been impressed by the performance of the LOBO vascular occluder in a wide variety of anatomies," commented Mr. Hoffman. "I look forward to working with the team to expand our commercial launch and make this important technology available to more physicians and patients." About Okami Medical Okami Medical, Inc. is a privately held medical device company with a mission to address the evolving needs of patients and physicians through the development of innovative, versatile, and intuitive devices for the occlusion of peripheral vessels. The company was created in 2017 by Inceptus Medical, a medical device incubator. The Inceptus team has a track record of creating innovative and successful companies including Inari Medical, Sequent Medical (acquired by Terumo in 2016) and MicroVention (acquired by Terumo in 2006). Okami is backed by members of the board of directors, Vensana Capital, U.S. Venture Partners (USVP), and medical device industry veterans. For more information, please visit . Source: Okami Medical, Inc. 949-446-9710 [email protected] SOURCE Okami Medical Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更并购

2024-11-29

·国家药品监督管理局

美敦力公司Medtronic, Inc.对心脏节律管理设备程控仪主动召回

美敦力（上海）管理有限公司报告，由于错误更新提示的原因,生产商美敦力公司Medtronic, Inc.对其生产的心脏节律管理设备程控仪Programmer（国械注进20242120424）主动召回。召回级别为三级召回。本次召回涉及的产品未进口至中国，具体型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表 2024年11月29日美敦力（上海）管理有限公司召回报表.pdf

2024-11-15

·国家药品监督管理局

美敦力公司MEDTRONIC INC.对顺行灌注插管主动召回

美敦力（上海）管理有限公司报告，由于包装密封问题，生产商美敦力公司MEDTRONIC INC.对其生产的顺行灌注插管Cardioplegia Delivery Cannula（国械注进20153101305）主动召回。召回级别为二级召回。本次召回涉及的产品未进口至中国，具体型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表美敦力（上海）管理有限公司召回报表.pdf 2024年11月15日

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