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Medillustrates
@Intervoke_Media brings complex medical tech to life with this stunning new 3D MOA animation developed with @LivaNova, detailing Proximal Hypoglossal Nerve Stimulation (PHGNS). Explore more: medillsb.com/artist.aspx?AID… #intervoke #livanova #medicalanimation #3danimation #medtech
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BrettSperryMD
ANTHEM-HFrEF is published in JACC and it’s one of the better trial stories I’ve read in a long time. Less about the device, more about what happened to the trial and how the authors handled it. 🧵 Background Vagal Nerve Stimulator for HFrEF. LivaNova’s Vitaria device. Adaptive Bayesian design, up to 1,000 patients planned. Primary endpoint CV death or HF hospitalization. NYHA II–III, EF ≤35%, all on GDMT. Controversy At 500 patients enrolled, the independent DSMB looked at the data and said keep going, no changes. LivaNova runs its own numbers, decides the benefit isn’t big enough to be worth it, and stopped the trial at 532. The board that’s supposed to make that call was overruled. Think about a team, up at the half, being told not to come out for the second. That’s not a loss. That’s a forfeit. And you can’t learn who was the better side from a game nobody finished. Were they winning? Sort of. Primary endpoint leaned the right way but missed: 34.6% vs 40.2%, HR 0.84 (0.62–1.12), P=0.115. Which is what happens when you are underpowered after cutting your enrollment in half. The signals underneath were better than the headline. KCCQ and NYHA class both improved significantly at 9 months. 6MWD trended the right way. Safety was excellent, 96.7% free of device or procedure SAEs against a 75% FDA bar. Heart rate variability went up, so the device was clearly doing something to the vagal nerve. The board saw all of that and said finish the trial. Courageous publishing The fact that this authors were able to write this type of paper is remarkable! The paper hammers home the point several times that the stop came from outside the DSMB process, that it left the trial underpowered, and that it changed their job into salvaging whatever science they could for the patients who’d already signed up. It’s about as pointed as trialists get in print. Read the acknowledgements This is the part I keep thinking about. The authors state plainly that “the investigators” means every author, including the ones employed by industry, and that those people were blinded, had nothing to do with the decision to stop, and were essential in mounting the response and getting the SAP addendum through FDA. Academic authors going on record to defend their industry co-authors against their own employer’s decision. That doesn’t happen often. @JACCJournals took it seriously The paper runs with two companion pieces: @ktkadakia and Dhruva’s “An Unfinished ANTHEM” on the ethics of sponsor-driven termination, and an editor-in-chief commentary from @hmkyale on what we owe people who enroll in trials. These patients got a device implanted. They took real risk on the understanding that it would produce knowledge. Killing the trial for commercial reasons, over the board’s objection, quietly breaks that deal after they’ve already taken the risk and can’t take it back. One thing I’d push back on I appreciate the attempt to re-power the endpoint given the limited sample size by using a win ratio. While still blinded, the team built this endpoint: CV death, HF hospitalization, plus KCCQ. Win ratio 1.25 (1.00–1.55). The presentation of the win ratio results is among the best I’ve seen, specifically showing the percentages and graphical representation of wins and losses with each end point (image attached). However, putting a subjective quality-of-life score into a win ratio in an open-label trial with no sham is asking for bias you can’t clean up later. To be fair, they flag this themselves and call it hypothesis-generating given the neutral primary, the multiplicity, and the marginal significance. Reasonable, but given the lack of sham control, I’d consider something less prone to placebo effect in the composite like 6MWT. Bottom line We can’t say whether VNS works here, and this trial was never allowed to answer that. The lasting lesson is about who gets to decide a trial’s fate once patients are enrolled. jacc.org/doi/10.1016/j.jacc.…
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145
whatdafuqkyle
@livanova for GFYS regards viz
6
StealthCoSpy
🔎Badri Amurthur is now building in Stealth Mode! Background: Ex-CTO at LivaNova, ex-VP of Business Development, co-founder of Corventis Location: San Francisco Bay Area, United States Connect on LinkedIn: linkedin.com/in/badri-amurth…
332
boominance
FirstSun Capital $FSUN — Raymond James | Outperform ➜ Strong Buy | TP $44 ➜ $47 Nike $NKE — BofA | Neutral | TP $55 ➜ $47 🚀 Initiations 5: Benzinga Abbott Labs $ABT — Baird | Outperform | TP $121 LivaNova $LIVN — Freedom Capital | Hold | TP $81 #FinanceNews #FinanceUpdate
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cflct_ngo
Together for Humanity 🤝 CFLCT & LivaNova Unite for Wheelchair Distribution 🙏. #WheelchairDistribution #ServeHumanity #BestNGOInDelhi #careforlifecharitabletrust Care For Life Charitable Trust
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13
MarcJacksonLA
$LIVN -KeyBanc raises LivaNova target to $92 from $83 Overweight - $LLY -Cantor reiterates Eli Lilly $1230 target Overweight -Morgan Stanley lowers target to $1135 from $1050 Hold - $LQDA -BTIG raises Liquidia target to $109 from $59 Buy -
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1,113
TCTMD
More than three years later, results for the ANTHEM-HFrEF trial of vagal nerve stimulation have been released. The study was initially halted by sponsor LivaNova despite the data and safety monitoring board (DSMB) urging its continuation. tctmd.com/news/anthem-hfref-…
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697
keithc3
The lawsuits also allege negligence and product liability claims against LivaNova USA Inc., the medtech company that manufactured the heater-cooler devices used in the surgeries. LivaNova remains a defendant in the cases. kansascity.com/news/local/ar…
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karen6406176726
I'm 42 years old and resigned from Fidelity. My annual income is 1.2 million US dollars. My May advice: $CBLL (Ceribell) — Don’t buy $OLED (Universal Display) — Don’t buy $BLSH (Bullish) — Don’t buy $ARM (Arm Holdings) — Buy at $219–$237 $IREN (IREN Ltd) — Buy at $55–$60 $AMSC (American Superconductor Corporation) — Buy at $53–$57 $LIVN (LivaNova) — Buy at $62–$66 People ask, “Why don’t you charge?” I’ve made enough. Sharing is my passion — that’s why I post for free.
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1,790
wallstengine
Today's Key Events (All EST) — 05/07 07:30: US Challenger Layoffs 08:30: US Initial Jobless Claims 11:00: NY Fed 1 Yr Inflation Expectations 14:05: Fed's Hammack Speaks 15:00: US Consumer Credit 15:30: Fed's Williams Speaks Before Open 👇 01:30: Novo Nordisk $NVO 05:20: Amcor $AMCR 05:30: NICE $NICE 06:00: Oscar Health $OSCR 06:00: Cenovus Energy $CVE 06:00: LivaNova $LIVN 06:00: CLEAR Secure $YOU 06:00: GEO Group $GEO 06:30: Hut 8 Mining $HUT 06:30: CVS Health $CVS 06:30: Apollo Global Management $APO 06:30: SharkNinja $SN 06:30: Restaurant Brands $QSR 06:30: ITT $ITT 06:30: BorgWarner $BWA 06:30: Cencora $COR 06:30: NiSource $NI 06:30: United Therapeutics $UTHR 06:40: Disney $DIS 06:55: Uber $UBER 06:55: Global Payments $GPN 06:55: Johnson Controls $JCI 07:00: fuboTV $FUBO 07:00: Kraft Heinz $KHC 07:00: Marriott $MAR 07:05: Instacart $CART 07:30: SolarEdge $SEDG 07:30: Medline $MDLN 08:30: UWM Holdings $UWMC After Hours 👇 16:00: Axon $AXON 16:00: Fastly $FSLY 16:00: Kratos Defense & Security Solutions $KTOS 16:00: Sezzle $SEZL 16:00: Sunrun $RUN 16:00: Symbotic $SYM 16:00: PTC 16:05: AppLovin $APP 16:05: IonQ $IONQ 16:05: Coherent $COHR 16:05: Arm $ARM 16:05: Fortinet $FTNT 16:05: Dutch Bros $BROS 16:05: Whirlpool $WHR 16:05: Ormat Technologies $ORA 16:05: Zillow $Z 16:05: DoorDash $DASH 16:10: Snap $SNAP 16:15: Albemarle $ALB Make sure to follow @wallstengine as I will be posting detailed earnings highlights for many companies
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14,132
baron_sky7
メモ✍️ 1. 直接Neuralink/BCI関連の強い上場企業 • ClearPoint Neuro (CLPT): 脳・脊髄へのナビゲーション・デリバリーシステムを提供。NeuralinkやBlackrock NeurotechなどのBCI企業の臨床試験・インプラント手術を支援するツールで、関連性が高い。 finance.yahoo.com • Medtronic (MDT): 大手医療機器企業。Precision Neuroscience(Neuralinkの元社員が創業した競合BCI企業)と提携・流通パートナーシップを結んでおり、BCI市場に間接参入。 marketwise.com • Hyperfine (HYPR): ポータブル脳MRI(Swoopシステム)を提供。BCI関連の脳イメージング需要で注目。 investorplace.com 2. 神経技術(Neurotech)・ neuromodulation分野の上場企業 これらはBCIに近い領域(脳刺激、診断など)で、Neuralinkの進展で全体市場が拡大する恩恵を受けやすいです。 • NeuroPace (NPCE): 応答性神経刺激(RNS)システムでてんかん治療。 • Inspire Medical Systems (INSP): 睡眠時無呼吸治療のインプラントデバイス。 • LivaNova (LIVN): 迷走神経刺激(VNS)でてんかん・うつ病治療。 • CVRx (CVRX): 心不全治療の神経調節デバイス。 • BrainsWay (BWAY): 非侵襲的深部経頭蓋磁気刺激(Deep TMS)。 • ONWARD Medical (ONWD / ONWRY): 脊髄損傷向けのデジタルブリッジ技術。 exoswan.com 3. 供給チェーン・周辺技術の上場企業 BCI開発に必要な部品・ツールを提供する企業群(例: イメージング、コンピュート、材料)。 • NVIDIA (NVDA): BCIの信号処理・AIデコーディングにGPUを提供(Synchronなどが使用)。 • Thermo Fisher Scientific (TMO): 電子顕微鏡などで脳マッピング研究を支える。 • Bruker (BRKR): 超解像顕微鏡。 • Butterfly Network (BFLY): 超音波チップ(非侵襲BCI研究で使用)。
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9,794
tenet_research
$LIVN | LivaNova reports 12 month results from OSPREY clinical study for obstructive sleep apnea published in Annals of Internal Medicine.
1,098
sensa_market
David Einhorn's fund is up 16.47% this quarter and his most contrarian bet is quietly sitting at 29% of the entire portfolio. The Greenlight Capital chief manages $2.05B with a deliberately diversified book, but one homebuilder dominates everything else. Here's the full breakdown: 1. Green Brick Title — 29% 2. (Multiple smaller positions cluster) — 22% 3. Consol Energy — 10% 4. Brighthouse Financial — 8% 5. Kyndryl — 6% 6. Tenet Health — 4% 7. Alight — 4% 8. ODP Corporation — 3% 9. QLD (SPDR Gold Shares) — 3% 10. Teck — 3% 11. LivaNova — 3% 12. Graphic Packaging — 3% 13. Weatherford — 3% 14. Net Power — 2% The 22% cluster includes: Gulfport, SPDR, Viatris, Seadrill, Herc, First Citizens BancShares, DHT, Invesco, New York Community Bank, Kenvue, VanEck, First Horizon, AerCap, Galapagos, GoPro, Coya Therapeutics, Sotera Health, First Trust, Teva, NeuBase Therapeutics, GAIN Therapeutics, Danimer Scientific, Talis Biomedical, Nuvation Bio, and Katapult. When a value investor known for shorting Lehman pre-2008 puts nearly a third of his fund into a single homebuilder and still posts 16% quarterly gains, the market is clearly missing something.
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468
medpagetoday
The FDA approved a proximal hypoglossal nerve stimulation device (aura6000 system) for adults with moderate to severe obstructive sleep apnea, maker LivaNova announced on Thursday. medpagetoday.com/pulmonology…
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281
medpagetoday
The FDA approved a proximal hypoglossal nerve stimulation device (aura6000 system) for adults with moderate to severe obstructive sleep apnea, maker LivaNova announced on Thursday. medpagetoday.com/pulmonology…
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289
tenet_research
$LIVN - LivaNova Receives U.S. Food and Drug Administration Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea .
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