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Thoratec Corporation Message Board

bigsmartsta 53 posts  |  Last Activity: Aug 16, 2016 10:38 AM Member since: Apr 21, 2005
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  • He is very entertaining. LOL!

  • What a failure motor-mouth is .... LOL!!!

  • All-cause mortality rate is 39% over six years

    January 14, 2016

    A long-term follow-up study of chronic heart failure patients treated with cardiac contractility modulation (CCM) has been published online in the International Journal of Cardiology. Those receiving CCM experienced significantly improved long-term survival compared with matched patients who did not receive CCM.

    In the analysis, 41 heart failure patients treated with CCM were followed for approximately six years and were compared with a matched group of 41 heart failure patients derived from a registry at the same hospital. All-cause mortality, the study’s primary endpoint, was significantly lower in the CCM group than in the control group (39% versus 71%, respectively; P = 0.001). In a subgroup of patients with baseline ejection fractions of between 25% and 40%, heart failure hospitalizations were also significantly lower in those who received CCM than in those who did not (36% versus 80%, respectively; P LT 0.001). The occurrence of heart failure hospitalization showed no significant difference between the CCM and control groups in the entire cohort (41% versus 49%, respectively), but was significantly lower in CCM-treated patients compared with the control patients in the subgroup analysis of those with baseline ejection fractions of between 25% and 40% (36% versus 64%; P= 0.005).

    CCM was administered using the Optimizer IVs (Impulse Dynamics), a minimally invasive implantable device for the treatment of chronic heart failure. The Optimizer IVs device has been launched in Europe and in other international markets, and has been implanted in approximately 3,000 patients to date. The device is available only for investigational use in the U.S.

  • It would be comical if he hadn't led the MB to such huge losses.

  • January 2016
    A long-term follow-up study of chronic heart failure patients treated with cardiac contractility modulation (CCM) has been published online in the International Journal of Cardiology. Those receiving CCM experienced significantly improved long-term survival compared with matched patients who did not receive CCM.
    In the analysis, 41 heart failure patients treated with CCM were followed for approximately six years and were compared with a matched group of 41 heart failure patients derived from a registry at the same hospital. All-cause mortality, the study’s primary endpoint, was significantly lower in the CCM group than in the control group (39% versus 71%, respectively; P = 0.001). In a subgroup of patients with baseline ejection fractions of between 25% and 40%, heart failure hospitalizations were also significantly lower in those who received CCM than in those who did not (36% versus 80%, respectively; P

  • If that isn't a PlSSER what is? LOL!

  • Another theory followed by no results is another big yawn. Where's the results on humans. Insects don't count.

  • “We thought our country was a safe place to be but now terror has come to our doorstep.”

  • bigsmartsta by bigsmartsta Jul 28, 2016 7:56 AM Flag

    With the latest offering it doesn't look like acquisition talks are in the picture.

    Now we don't even have a schedule for a CC yet???

    I wonder if SSH has run into patent problems with Impulse Dynamics CCM technology?

  • On March 23, 2016, the Nasdaq Stock Market ("Nasdaq") notified Sunshine Heart, Inc. (the "Company") that it no longer complies with Rule 5550(a)(2) (the "Minimum Bid Price Rule"), as the bid price of the Company's shares of common stock ("Common Stock") closed below the minimum $1.00 per share for the 30 consecutive business days prior to the date of the notice. In accordance with Rule 5810(c)(3)(A), the Company will be provided 180 calendar days, or until September 19, 2016, to regain compliance with the Minimum Bid Price Rule. The Company may regain compliance with the Minimum Bid Price Rule if the closing bid price of the Common Stock is $1.00 per share or more for a minimum of 10 consecutive business days at any time before September 19, 2016.

    The Nasdaq letter further states that if compliance with the Minimum Bid Price Rule cannot be demonstrated by September 19, 2016, the Company may be eligible for a second 180 day period to regain compliance. To be eligible for the second 180 day compliance period, (i) the Company must meet the market value of publicly held shares requirement for continued listing and all other applicable standards for initial listing on The Nasdaq Capital Market set forth in Marketplace Rule 5505 (except the bid price requirement), (ii) the Company must provide Nasdaq with written notice of its intention to cure the deficiency, through a reverse stock split, if necessary, and (iii) Nasdaq must determine that the Company will be able to cure the deficiency.

    If the Company does not regain compliance with the Minimum Bid Price Rule prior to September 19, 2016 and is not eligible for the second 180 day compliance period, then Nasdaq will notify the Company that the Common Stock will be subject to delisting. At such time, the Company may appeal Nasdaq's delisting determination.

  • bigsmartsta bigsmartsta Jul 25, 2016 6:56 PM Flag

    The mechanism by which CCM provides benefit can be seen at the cellular level where improved calcium handling (phosphorylation of phospholamban, upregulation of SERCA-2A), reversal of the fetal myocyte gene program associated with heart failure, and reverse remodeling are observed. Recent retrospective studies indicate a long-term mortality benefit. A pivotal randomized controlled study is currently being completed in the USA. CCM appears to be an effective, safe technology for the treatment of heart failure with reduced ejection fraction.

  • Heart Fail Rev. 2016 Jul 9

    Abi-Samra F1, Gutterman D2.

    Heart failure is a major health problem worldwide and, despite effective therapies, is expected to grow by almost 50 % over the next 15 years. Five-year mortality remains high at 50 % over 5 years. Because of the economic burden and large impact on quality of life, substantial effort has focused on treatments with multiple medical (beta-blockers, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers (ARB), aldosterone antagonists, and combination of ARB/neprilysin blockers, ivabradine) and device therapies (ICD, CRT) which have been implemented to reduce disease burden and mortality. However, in the past decade only two new medical therapies and no devices have been approved by the US FDA for the treatment of heart failure. This review highlights the preclinical and clinical literature, and the implantation procedure, related to a relatively new therapeutic device for heart failure; cardiac contractility modulation (CCM). CCM delivers a biphasic high-voltage bipolar signal to the RV septum during the absolute refractory period, eliciting an acute increase in global contractility, and chronically producing a sustained improvement in quality of life, exercise tolerance, and heart failure symptoms. The technology is used commercially in Europe with nearly 3000 patients implanted worldwide. Indications include patients with reduced EF and normal or slightly prolonged QRS duration, thus filling an important therapeutic gap among the 2/3 of patients with heart failure who do not meet criteria for CRT. The mechanism by which CCM provides benefit can be seen at the cellular level where improved calcium handling (phosphorylation of phospholamban, upregulation of SERCA-2A), reversal of the fetal myocyte gene program associated with heart failure, and rever

  • bigsmartsta bigsmartsta Jul 25, 2016 2:58 PM Flag

    The mechanism by which CCM provides benefit can be seen at the cellular level where improved calcium handling (phosphorylation of phospholamban, upregulation of SERCA-2A), reversal of the fetal myocyte gene program associated with heart failure, and reverse remodeling are observed. Recent retrospective studies indicate a long-term mortality benefit. A pivotal randomized controlled study is currently being completed in the USA. CCM appears to be an effective, safe technology for the treatment of heart failure with reduced ejection fraction.

  • Heart Fail Rev. 2016 Jul 9. [Epub ahead of print]

    Cardiac contractility modulation: a novel approach for the treatment of heart failure.

    Abi-Samra F1, Gutterman D2.

    1, 1516 Jefferson Hwy, New Orleans, LA, 70121, USA.
    2MD Medical College of Wisconsin, Milwaukee, WI, 53226, USA. dgutt@mcw.edu.

    Abstract

    Heart failure is a major health problem worldwide and, despite effective therapies, is expected to grow by almost 50 % over the next 15 years. Five-year mortality remains high at 50 % over 5 years. Because of the economic burden and large impact on quality of life, substantial effort has focused on treatments with multiple medical (beta-blockers, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers (ARB), aldosterone antagonists, and combination of ARB/neprilysin blockers, ivabradine) and device therapies (ICD, CRT) which have been implemented to reduce disease burden and mortality. However, in the past decade only two new medical therapies and no devices have been approved by the US FDA for the treatment of heart failure. This review highlights the preclinical and clinical literature, and the implantation procedure, related to a relatively new therapeutic device for heart failure; cardiac contractility modulation (CCM). CCM delivers a biphasic high-voltage bipolar signal to the RV septum during the absolute refractory period, eliciting an acute increase in global contractility, and chronically producing a sustained improvement in quality of life, exercise tolerance, and heart failure symptoms. The technology is used commercially in Europe with nearly 3000 patients implanted worldwide. Indications include patients with reduced EF and normal or slightly prolonged QRS duration, thus filling an important therapeutic gap among the 2/3 of patients with heart failure who do not meet criteria for CRT. The mechanism by which CCM provides benefit can be seen at the cellular level where improved calcium handling (phosphorylation of

  • Minneapolis – June 6, 2016 – CVRx, a global medical device company, today announced that the first two patients have been treated with the BAROSTIM NEO® System in the Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF). The procedures were done at the University of California San Francisco and Abrazo Arizona Heart Hospital in Phoenix, Arizona. More than 20 patients have been enrolled and are being evaluated for eligibility.

    BeAT-HF is a Phase III randomized, controlled clinical trial that studies the safety and efficacy of BAROSTIM THERAPY, the only therapy that is designed to simultaneously reduce sympathetic nervous system activity while restoring parasympathetic activity, for the treatment of heart failure. The trial will randomize 480 patients who suffer from heart failure with a reduced ejection fraction and who have no additional treatment alternatives available. BeAT-HF has achieved Expedited Access Pathway (EAP) designation by FDA for its focus on this unmet clinical need.

    “We are very excited by the enrollment and treatment of the first patients in the BeAT-HF Pivotal Clinical Trial. The patients we are including suffer from a very poor quality of life and an increased risk of heart failure-related hospitalizations, and they have no further treatment options,” said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair of the BeAT-HF Executive Steering Committee. “BAROSTIM THERAPY has already demonstrated unprecedented symptom improvement through HOPE4HF, a Phase II randomized, controlled clinical trial, and we are looking forward to similar patient outcomes during BeAT-HF.”

  • And Hillary wants even more of them let into this country?

    Does anyone remember the movie 'The Manchurian Candidate.' I wonder what the theme would be if the word 'Manchurian' was replaced with .....? I wonder if Trump was correct when he doubted someone's true religion and place of birth?

  • He doesn't realize what he believes has no importance. LOL!!!

  • bigsmartsta bigsmartsta Jul 13, 2016 1:25 PM Flag

    "due to the Barostim’s acceptance in the accelerated approval pathway, the FDA will likely allow commercialize to commence before then, as long as the device demonstrates safety during the trial."

    What data was viewed by the FDA that resulted in "accelerated approval pathway"?

  • bigsmartsta bigsmartsta Jul 13, 2016 12:01 AM Flag

    In addition, another trial to test the device on heart failure patients is recruiting subjects. Its primary endpoint of (the rate of cardiovascular mortality and heart failure morbidity) is scheduled to report in 2021. Crucially, due to the Barostim’s acceptance in the accelerated approval pathway, the FDA will likely allow commercialize to commence before then, as long as the device demonstrates safety during the trial.

    In an email, CVRx CEO Nadim Yared said the company has not yet decided to comment on its Series G round.

  • Jun 18, 2016 at 7:00 AM

    Minneapolis’ CVRx has raised $46 million from unnamed investors in support of its implantable neuromodulator to treat high blood pressure and heart failure, bringing its total equity funding to $237 million over 5 rounds, according to CrunchBase.

    CVRx boasts the CE-marked Barostim Neo, an entrant into FDA’s Expedited Access Program for accelerated approval of innovative devices that “demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.”

    Neuromodulation is gaining ground as a therapy for reducing pain, but no one has yet harnessed it within the cardiology arena, putting the company in a unique position if the Barostim gains FDA approval and commercial success.

    “Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies,” Dr. William Abraham, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, said in a statement when the device gained acceptance into the accelerated pathway.

    New Enterprise Associates and Johnson & Johnson Development Corporation, co-led CVRx’s $42 million Series F round in 2013.

    The device’s 310-patient pivotal trial is slated to conclude in September 2017, according to ClinicalTrials.Gov. The primary efficacy endpoint is a reduction in blood pressure six months after activation of the device compared to the medical management arm.

    In addition, another trial to test the device on heart failure patients is recruiting subjects. Its primary endpoint of (the rate of cardiovascular and heart failure morbi

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