Kar said, “We do agree that this is not a first-line therapy, but those people who . As seen previously, the rate of ischemic stroke/systemic embolism was numerically higher—though not significantly so—with the Watchman device (1.6% vs 0.95%; P = 0.08). of controversy and the added data from the long-term follow-up, the FDA approved the Watchman device in March 2015 for use in patients with nonvalvular AF with CHA2DS2-VAScscore 2,acknowledgingthatthebenefits associated with the Watchman may outweigh its risks, especially in patients unsuitable for or not wanting life-long AC. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. , I think that’s a no-brainer,” Sommer said. Studies highlight complications associated with stroke device. Take a look at this article in The Times.It tells the story of Oxford professors named Martin Landray and Peter Horby. “And by minimizing major bleeding, particularly hemorrhagic stroke, left atrial appendage [closure] results in less disability or death in comparison to warfarin,” he continued. 3,62 To date, at least 1 left atrial appendage occlusion device, the Watchman left atrial appendage device … Left atrial appendage occlusion (LAAO), also referred to as Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the … The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices… […], The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as a Medical Device (SaMD). and 0.018 in. greater rigor, ... Current Status and Future Directions in the Controversy over Stenting. Prevention and avoidance of the devastating consequences of thromboembolic complications from AF continues to be central in the management of these patients. Both air emboli and device embolization can cause a patient’s stroke. While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. “The patients all want it. The physicians all want it. It extracts personal data from android mobiles or iPhones (locked or encrypted) and reaches beyond the device itself into social media and Cloud-based sources or apps, such as Snapchat and Instagram, without requiring any permission and in turn bypassing administrative controls . made thee a watchman unto the house of Israel, Ezek. He added that if Watchman was not preventing ischemic stroke, events would have increased after postprocedural antithrombotic therapy was stopped, which wasn’t the case. underwent WATCHMAN device implantation had a reduced risk of stroke (2.3% per year) compared with the expected thrombo-embolic risk (7.3% per year).26 The ASAP TOO (NCT02928497) randomised trial is currently enrolling patients with a contrain-dication to anticoagulation to further assess the WATCHMAN’s efficacy in this population. The WATCHMAN device is implanted via a minimally invasive procedure, meaning it does not require open surgery. “It’s important to recognize that, and as a result, I think we have to really be careful in our assessments of individual patients and try to determine what is your bleeding risk, how much benefit am I going to get from this.”, He said it’s unclear how extensive a role Watchman should have. “Therefore, we feel that for patients who are poor candidates for long-term oral anticoagulation—[with] emphasis on the word long-term—left atrial appendage closure is a reasonable strategy for stroke prevention.”. Data for Watchman indicate that ischemic stroke rates are higher, at 1.3% to 1.8%, whereas untreated patients have rates in excess of 5%, he noted. He got his start in journalism at …. The agency allowed investigators to borrow some data from PROTECT AF—which would be incorporated using Bayesian methodology—to limit the size of PREVAIL. TCTMD All rights reserved. With all medical procedures there are risks associated with the implant procedure and the use of the device. Combining patient-level data from both trials showed that the rate of stroke, systemic embolism, or cardiovascular death was similar in the Watchman and warfarin arms (2.8% vs 3.4%; OR 0.82; 95% CI 0.58-1.17). "Go Set a Watchman" was on the shelves. Key approvals on the original series remain on the expanded… […], Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. Instead it mostly focuses on the struggles of a young Native American woman. The device is intended to remain inside a patient’s heart permanently. The plan is a response to feedback received from the agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” It outlines five actions that the FDA… […], The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. Briefing documents released ahead of Wednesday's panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak … But some experts suggested that it is not realistic to expect a device that occludes the LAA to perform as well as a systemic therapy like warfarin because there are many causes of ischemic stroke. “Just from a biological plausibility standpoint, I would never expect a device that addresses only one specific cause of stroke to then somehow normalize stroke between long-term anticoagulation and this device, because there are other sources of emboli that don’t come from the left atrial appendage,” Robert Yeh, MD (Beth Israel Deaconess Medical Center, Boston, MA), a panelist at the press conference, told TCTMD. 33:7. watchman of Ephraim was with my God, Hosea 9:8. day of thy watchmen and thy visitation cometh, Micah 7:4. priests and elders … to preside and watch over the church, Alma 6:1. set watchmen round about them, D&C 101:45. He tells his patients that oral anticoagulation is first-line therapy based on data showing annual stroke rates of 1% or less. An article by BioCentury also said that former FDA commissioner David Kessler, who had been mentioned as a possible replacement for current commissioner Stephen Hahn, will be a consultant to the agency but will not… […], Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year. “Therefore, we don’t think that ischemic stroke was higher than expected” with Watchman, Kar said. Mean follow-up for the 1114 total patients was about 4 years. The WATCHMAN implant device … J Am Coll Cardiol. The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. Reddy et al write that the trials “have been concordant in demonstrating non-inferiority of Watchman to warfarin for stroke or systemic embolism, and superiority in reducing hemorrhagic stroke, cardiovascular mortality and non-procedure related … They do not store directly personal information, but are based on uniquely identifying your browser and internet device. Written to preserve the memory of the US government’s attempt to close Indian reservations in the 1950s, only a small part of the book is actually devoted to narrating this controversy. These medtech stocks performed the best in 2020, Medtronic launches deep brain stim trial for Parkinson’s disease, Former FDA commissioner Kessler to help lead Biden’s COVID-19 response, Facial swelling and COVID-19 vaccines: 4 facts, Here’s what molecular shape can tell you about pharma innovation, Norway investigating deaths of 23 individuals who received COVID-19 vaccine, 3M, Honeywell gain antitrust protection to boost N95 mask supply, Ex-Acclarent execs fined $1.5M in off-label marketing case, Former CDER head Woodcock to lead FDA for now, Prosecutors want to present evidence of Elizabeth Holmes’ quest for wealth and fame, TransEnterix raises more than $31M in stock offering, Boston Scientific launches WaveWriter Alpha spinal cord stim. The second trial, which enrolled 407 patients, showed fewer complications but provided an inconclusive assessment of efficacy; only one of the two composite efficacy endpoints established the noninferiority of Watchman versus warfarin. The Watchman was still an investigational product in the United States in April 2009 when an FDA advisory committee reviewed the findings from manufacturing, bench, and clinical testing of … I had the watchman device fitted in 2016/17. The Night Watchman is an impressive literary feat. Panelists at the press conference and at Kar’s main presentation debated how Watchman should be used, and there was consensus that it should be judiciously incorporated into practice. But there were safety concerns, including increases in serious pericardial effusion and procedural ischemic stroke in the Watchman arm. “We know that using the device plus withholding anticoagulation severely reduces bleeding,” Yeh said. “In that context, in patients with high CHA2DS2-VASc scores, I think that’s a no-brainer,” Sommer said. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. by an FDA advisory committee in October 2014, which resulted in unanimous support for Watchman’s safety but a split vote on the question of efficacy. Here is the problem: The … Both of the two original trials of the Watchman device — PROTECT-AF and PREVAIL — excluded patients with AF who had perceived contraindications to oral anticoagulation, including prior … That might be where the sweet spot is,” he said. However, noninferiority criteria were met for the other coprimary composite endpoint of postprocedural ischemic stroke/systemic embolism. Specifically, it is a parachute-shaped, self-expanding device that is placed in the opening of the LAA. The future of the Watchman procedure; The Watchman Device. This video shows the procedure for the Watchman, a left atrial appendage closure device. He added that if Watchman was not preventing ischemic stroke, events would have increased after postprocedural antithrombotic therapy was stopped, which wasn’t the case. If you are undergoing a left atrial appendage closure (LAAC) WATCHMAN procedure for stroke prevention, then you will be admitted to the hospital for a short stay. Enter the email you used to register to reset your password. Nevertheless, the device earned the elusive approval of the FDA in the spring of 2015. Watchman probably effectively addresses emboli coming from the LAA, but anticoagulation has an additional benefit, he added. The WATCHMAN™ Device is permanently implanted at or slightly distal to the ostium (opening) of the LAA, which is known to be the source of more than 90% of stroke-causing bloods clots in people with … In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic… […]. The device can detect where faulty heart beats are occurring, allowing treatment to be tailored. Also, once the device has been in for months, the body walls it off and the patient can stop the anticoagulant drug (warfarin, or one of the new drugs, called NOAC s). Kar reports having received research grants from and having served as a consultant for Abbott Vascular and Boston Scientific; having served as a member of the advisory board for LAA closure; being the national principal investigator of the Continuous Access Registries (CAP and CAP2); and having served as a proctor for Boston Scientific. 9:5, 6, 10. that they “know not anything” shows us that “There is no work, nor device, nor knowledge, nor wisdom, in the grave.” Even the prosperity or adversity of their best loved relatives, produces no emotion, either of joy or sorrow. As clinicians, we … Reddy et al write that the trials “have been concordant in demonstrating non-inferiority of Watchman … by the US Food and Drug Administration (FDA) in March 2015. The Watchman device seals off the left atrial appendage in the heart, which is the major source of stroke-causing thrombus in AF patients. DPI uses vertical presses for over-molding and insert-molding, capabilities often required for medical… […], Traco Power announced that it has expanded its TPP 450 high-density 3×5 power supply series. The series now offers Protection Class II models (TPP 450BA-M Open-Frame Models and TPP 450B-M Enclosed with Fan Models), designed for non-stationary requirements where connection to ground is not possible. April 15, 2015. Love him or hate him, it’s fair to say Johns faces a formidable challenge taking on the “Watchmen” mantle. CHA2DS2-VASc scores, with a line for untreated patients and a line for warfarin-treated patients. It’s cram-packed with shocks, thrills and complex characters that blur the lines between hero and villain. The difference in ischemic stroke, then, appears to be related to the low 0.73% annual rate in the warfarin arm. WTWH Media LLC and its licensors. Therefore, there's a new iteration of the WATCHMAN device where there are certain changes, such as now you can use that newer device … The numerically higher rate of ischemic stroke with the Watchman remained both in PREVAIL alone and in the meta-analysis of the two trials, and the investigators say in their paper, “Although PREVAIL was not powered to examine differences in ischemic stroke, the question nonetheless remains: why the difference? To implant WATCHMAN, your doctor makes a … “It’s certainly going to be a problem for their physicians.” He pointed out, however, that ischemic stroke rates could be different for other LAA closure devices. The Ongoing Debate Over Watchman The discussion over procedural safety overlooks a larger controversy about the efficacy of Watchman. They then plotted the point estimates for ischemic stroke in PREVAIL and other Watchman studies and found that the confidence intervals crossed the warfarin line. What's involved in the WATCHMAN procedure? The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media. (Story updated Friday, November 13 at 12:55 p.m. Receive the the latest news, research, and presentations from major meetings right to your inbox. TCTMD is produced by the Cardiovascular Research Foundation (CRF). FDA approval of the left atrial appendage closure device after a long review process provides a potentially useful alternative to warfarin. “The population that really needs this is warfarin-ineligible patients,” he explained, adding that there is no appropriate, controlled method of studying the device in this patient group. It’s a permanent device that doesn’t have to be replaced and can’t be seen outside the body. All differences were statistically significant, Saibal Kar, MD (Cedars-Sinai Medical Center, Los Angeles, CA), reported at TCT 2017. While the patient is under general anesthesia, a … CRF is committed to igniting the next wave of innovation in research and education that will help doctors save and improve the quality of their patients’ lives. Watchman device insertion complications can lead to life-threatening injuries or death. Cardiologists who are trained to put the device in often speak on behalf … They then plotted the point estimates for ischemic stroke in PREVAIL and other Watchman studies and found that the confidence intervals crossed the warfarin line. We implant the WATCHMAN device … We implant the WATCHMAN device similar to a stent, in which a narrow tube is inserted through a small opening in the upper part of your leg. ET.) Then again, when has Johns ever been afraid of controversy? WATCHMAN is implanted into your heart in a one-time procedure. Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. For those tested, studies demonstrated acceptable deflection angles, torque, and MR-related heating with regard to the intended in vivo uses of these specific devices. Boston Scientific's Watchman device seals off the left atrial appendage so blood can't coagulate and escape into the arteries. The Watchman LAA device has been linked to complications that can arise during the implantation procedure. I had it because I couldn't take anti coagulants due to 2 separate strokes, the first being a clot (so was put on anti coagulants), and then … . Ablation Vs. Medical Therapy for Atrial Fibrillation: Putting CABANA in Perspective. Solomon’s statements concerning the dead Eccl. Subscribe for $5.00. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. The agency allowed investigators to borrow some data from PROTECT AF—which would be incorporated using Bayesian methodology—to limit the size of PREVAIL. [Epub ahead of print]. That prompted the FDA to request a second trial—which became. The company… […], Diversified Plastics (DPI) announced that it recently installed six all-electric vertical injection molding presses. The WATCHMAN device was approved for sale in Europe in 2005 and some countries in Asia in 2009. Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just … The Watchman Device is a small implant placed in to the heart that … For patients with lower bleeding risks, however, “I don’t think at this point we have any data to support that we should move away from anticoagulation and toward a left atrial appendage occlusion device,” he said. Nevertheless, the device earned the elusive approval of the FDA in the spring of 2015. What is the Watchman Device (Also known as Watchman Procedure, Watchman Heart Procedure or Watchman Implant)? What’s next for the FDA and for Stephen Hahn? Confusing the issue was a lower-than-expected rate of ischemic stroke in the warfarin arm. Also consistent with prior reports, only one of the two co-primary efficacy endpoints in PREVAIL established the noninferiority of Watchman versus warfarin at 5 years. ... Rediscovered 'Go Set a Watchman' draws buyers, controversy HOWARD YUNE [email protected]. Don’t worry, there are 2.2 million more copies for you to buy, we’re told. , although the agency remained unconvinced. This content is available for meeting attendees and/or Platinum Members. That led to an unprecedented third vetting by an FDA advisory committee in October 2014, which resulted in unanimous support for Watchman’s safety but a split vote on the question of efficacy. 3:17. son of man, I have set thee a watchman unto … Israel, Ezek. “I think for those patients who are at prohibitive risk for bleeding, this device needs to be discussed,” Yeh suggested. It’s a very easy decision to make.”. For panelist Brian Whisenant, MD (Intermountain Medical Center Heart Institute, Salt Lake City, UT), the long-term data from PREVAIL and PROTECT AF can be useful when discussing treatment options with patients. The cost of the Watchman device is covered by Medicare and Medicaid as of February 8, 2016. In 2013, an FDA advisory panel. The procedure takes about an hour. Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. It is the only device of its kind … Hi Jennywren. The WATCHMAN Left Atrial Appendage Closure Device is implanted at the opening of the left atrial appendage and is intended to prevent left atrial appendage blood clots from entering your blood … ... Watchman Device Provides Physicians with New Options in Atrial Fibrillation. When they saw the pandemic unfolding in China and Lombardy, their first thought was to design a proper clinical trial to determine what works for COVID19. Seguridad y eficacia a corto plazo del cierre de orejuela izquierda con dispositivo WATCHMAN ® en fibrilación auricular no valvular en pacientes con alto riesgo de sangrado Short-term safety and efficacy of left atrial appendage closure using WATCHMAN ® device for non-valvular atrial fibrillation in patients with a high risk of bleeding “Can you get the bleeding benefit and still get the stroke reduction of a left atrial appendage occlusion device? Many futurists have speculated that we may one day be able to scan the human brain and “upload” it to a computer. “It’s shown that it can give results that are at least noninferior in this setting, knowing that the noninferiority margins are wide.”. Panelists were concerned about a numerical increase of ischemic stroke in the Watchman arm of PREVAIL. As prespecified, both trials had a maximum follow-up of 5 years, and Kar presented the final results of PREVAIL, both alone and in combination with PROTECT AF. Yeh said that raises the possibility of studying a strategy that combines implantation of the Watchman device to plug the LAA and continued treatment with a low dose of a non-vitamin K antagonist oral anticoagulant (NOAC) to deal with additional causes of stroke. The only “critical issue” will be for which patients the device will be indicated, Dr. Sommer added, since all of the Watchman trials, except ASAP, included only warfarin-eligible patients. Debate around findings of the multicenter CABANA study of ablation versus drug therapy for atrial fibrillation shouldn’t distract from why patients seek ablation in the first place: symptom relief. It is already commercially available in 40 countries worldwide. Spiritual Man Watchman Nee The Spiritual Man Watchman Nee Getting the books the spiritual man watchman nee now is not type of inspiring means You could not and no-one else going like books accrual or library or borrowing from your contacts to entry them This is an unquestionably Page 1/27 Submission And Authority By Watchman Nee The findings were published simultaneously online in the Journal of the American College of Cardiology. Stay up-to-date with breaking news, conference slides, and topical videos covering the spectrum of CVD. 5-year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials. Or if the anatomy of the left atrial appendage whereby the [intangible] is too large and the appendage is too short, the currently available WATCHMAN device, approved WATCHMAN device, cannot be used. In the PROTECT AF trial, LAA closure with the WATCHMAN device demonstrated the potential for a device-based approach to reduce the risk of stroke in AF patients. “So while the Watchman device may not provide the absolute reduction in ischemic stroke rate that oral anticoagulants [do], a stroke rate of less than 2% is a whole lot better than no therapy for many of these patients,” Whisenant said. The Watchman device is used to close off the left atrial appendage. To address whether Watchman had suboptimal performance, the researchers plotted expected stroke rates as a function of. In the first randomized trial to evaluate the device—PROTECT AF, which started in 2005 and enrolled 707 patients—Watchman was shown to be noninferior to warfarin for stroke prevention. In 2013, an FDA advisory panel again voted to approve the device, although the agency remained unconvinced. The book instantly flew to the top of the New York Times bestseller list, and with 1.1 million copies sold in a week, HarperCollins announced that it had become the “fastest-selling book in company history.” But as quickly as it sold, the controversy … Kar pointed out that this is the lowest rate seen in any trial of warfarin, with rates typically ranging from 1% to 2%. Unlimited articles on any device Skip article surveys. Apple magnetic charger, smartwatch may deactivate Medtronic ICD, FDA debuts plan for AI-based Software as a Medical Device, Covestro tests plastics against high-strength hospital disinfectants, Diversified Plastics adds high-efficiency vertical presses, Traco Power expands power supply line for portable medical equipment, Reflow Medical launches low-profile reinforced support catheters, EU allows remote audits for medical devices during pandemic. Panelists were concerned about a numerical increase of ischemic stroke in the Watchman arm of PREVAIL. “The long-term 5-year outcomes of two randomized trials have demonstrated that left atrial appendage closure with the Watchman device provides stroke prevention in nonvalvular atrial fibrillation patients to a similar degree as oral anticoagulation,” he said during his presentation. The second trial, which enrolled 407 patients, showed fewer complications but provided an inconclusive assessment of efficacy; only one of the two composite efficacy endpoints established the noninferiority of Watchman versus warfarin. In the first randomized trial to evaluate the device—, , which started in 2005 and enrolled 707 patients—Watchman was shown to be noninferior to warfarin for stroke prevention. For more information, visit http://www.crf.org. But there were safety concerns, including increases in serious pericardial effusion and procedural ischemic stroke in the Watchman arm. . gained from the WATCHMAN® device experience ar e utilized to instantiate a proposal for 39 . The WATCHMAN procedure and left atrial appendage closure device is a first-of-its-kind, proven alternative to commonly-used blood thinner warfarin to prevent stoke in patients with atrial fibrillation or an abnormal heart beat. WATCHMAN is the only device of its kind approved by the U.S. Food and Drug Administration (FDA) for reducing the risk of stroke in people with atrial fibrillation not caused by a heart valve problem. “The patients all want it. The low number of warfarin-treated patients and the wide confidence intervals indicate that the unusually low rate is due to chance, Kar said. Copyright © 2021. The physicians all want it. Study Design. The device … For those tested, studies demonstrated acceptable deflection angles, torque, and MR-related heating with regard to the intended in vivo uses of these specific devices. Next-generation Watchman LAAC device gains US FDA approval 22nd July 2020. As seen previously, the rate of ischemic stroke/systemic embolism was numerically higher—though not significantly so—with the Watchman device (1.6% vs 0.95%; The findings were published simultaneously online in the, In concluding his presentation, Kar said, “We have prevailed,” riffing on one of the trial names and alluding to the long journey the Watchman device had to undertake before. RELATED: The 15 Best Hidden Treasures in Watchmen . The WATCHMAN device is a one-time, permanent implant that reduces the risk of stroke in patients with AFib, eliminating the need for and long-term risk of bleeding caused by blood thinners such as warfarin. Hahn’s brief tenure at FDA has been rocky, to say the least. Damon Lindelof recently opened up about "Watchmen" being rebranded as a limited series for the 2020 Emmys. The Ongoing Debate Over Watchman The discussion over procedural safety overlooks a larger controversy about the efficacy of Watchman. Confusing the issue was a lower-than-expected rate of ischemic stroke in the warfarin arm. “Therefore, we don’t think that ischemic stroke was higher than expected” with Watchman, Kar said. The traditional treatment for clot prevention in patients … The WATCHMAN Device is an alternative to blood thinners now available to prevent blood clots from forming in the hearts of patients with A-Fib. These presses will join DPI’s existing assemblage of vertical presses and provide increased production capacity to meet growing demand from medical device and other original equipment manufacturers (OEMs). “The long-term 5-year outcomes of two randomized trials have demonstrated that left atrial appendage closure with the Watchman device provides stroke prevention in nonvalvular atrial fibrillation patients … As is customary for rapidly assessing the compatibility of plastics to disinfectants, test specimens were pre-strained and underwent several wipe-and-dry cycles with Metrex disinfectants to… […], Integer announced today that it recently broke ground on an expansion of its Alden, N.Y., facility to accommodate new equipment that will substantially increase the plant’s production capacity for rechargeable Xcellion lithium-ion batteries. It’s hard to blame him. The Watchman device has been advertised heavily, both to the public, in medical journals, and at medical conferences. iStockphoto / iculizard ‘I Told You So’ In under a week, Harper Lee’s Go Set A Watchman has sold more than 1.1 million copies in the States, according to HarperCollins, as reported by Sarah Weinman at Publishers Lunch. The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA. PREVAIL and PROTECT AF were funded by Boston Scientific. We’ll then carefully place the WATCHMAN device into the appropriate location in your heart. Eur Heart J. When looking at other patients who might want to avoid anticoagulation, like younger, active people, however, the trend toward higher ischemic stroke rates with Watchman could be a problem, he added. 2017;Epub ahead of print. As seen in the results of the primary analysis of PREVAIL reported in 2013, the noninferiority of Watchman versus warfarin was not established for the coprimary composite endpoint of stroke, systemic embolism, or cardiovascular/unexplained death at the latest follow-up. —in a slightly higher-risk cohort, despite one of its advisory panels voting in favor of approval on the basis of the PROTECT-AF results. The Watchman device has a proven record of safety, with more than 20,000 procedures performed worldwide and over 10 years of clinical studies in some 2,000 patients. A cardiologist - usually an interventional cardiologist or electrophysiologist - uses tiny tubes called catheters to deliver the device … They come in 0.014 in. It’s a very easy decision to make.”. , which is the Associate news Editor for TCTMD and watchman device controversy Senior Medical.! Due to chance, Kar said draws buyers, controversy HOWARD YUNE hyune @ napanews.com Putting CABANA Perspective! 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