no interest. I guess one has to have bought a bunch under .50 to be interested :)
Keith Williams .
Keith began his career as a research scientist (developmental biology, biochemistry, molecular biology) at the Australian National University, University of Oxford (UK), the Max Planck Institute for Biochemistry (Munich, Germany) and finally Macquarie University (Sydney) where he held a Chair in Biology and established the Centre for Analytical Biotechnology. Pioneering the area of proteomics (with Marc Wilkins in his group coining the term), Keith established the world’s first government-funded Major National Proteomics Facility (Australian Proteome Analysis Facility) which was involved with industrialising protein science.
New article on Seeking Alpha SSH Summary
•Two choices for large markets for Class III heart failure: stem cells or simple devices.
•The needle: stem cell therapies (Mesoblast, NeoStem) offer promise, but struggle with late stage clinical trials.
•Is the stem cell field too immature yet for successful heart repair?
•The knife: Sunshine Heart's C-Pulse is a simple heart assist device that gives the heart a rest.
•Sunshine Heart's C-pulse is simple and progressing along a well worn path to a fully implantable device (think pacemaker).
Of all the organs in the body, the heart has mystical and romantic significance, but it is one of the most prosaic of organs… it's just a pump! The problem is that it is a pump that can never fail. Failure means death.
While the technology of heart transplants is mature, there are not enough hearts available and it would be better to be able to address the problem of a failing heart earlier and less traumatically. LVADs (Left Ventricular Assist Devices) are a holding pattern, but it's doubtful that they will ever be more than a temporary solution as a bridge to transplantation. Although some LVADs are being adopted as a long-term solution, risks associated with them being inserted into the bloodstream make it challenging to imagine that they will ever make a big impact as a permanent solution to treating earlier stages of heart failure (such as NYHA Class III).
So what is out there?
Do patients implanted with the C-Pulse have 1. an improved quality of life 2. do the #s indicate a longer life span after impalnt than not! Then if the patient does die - was it due to some comorbidity or 2. do to some malfuction of the device. The FDA is well aware of the 100% death rate for all of HF patients...... well they probably are aware there is a 100% death rates for all humans... :) IMO I'd take my chances with the C-Pulse. I took my chances with a single lead pacemaker and a battery that does not need to be replaced in 10 years. About 30 years ago there were lots of questions about pacemakers would they work, would they improve quality of life, would they kill you --- let along the advances in battery life... and that's with something that is really nundane as a cardiac pacemaker.
22 = google seekingalpha you can sign up. type in SSH and can get all the reviews and comments better source than yahoo
The "Physician Subject Selection Committee" is a great step by Sunshine Heart to ensure the patients most suited for C-Pulse are the ones actually selected.
While there are inclusion and exclusion criteria, it does not mean every potential enrollee who meets all of those criteria, will necessarily be a good candidate for C-Pulse.
For example, while a patient might meet all of the criteria, they could be borderline on a number of the exclusion criteria, which overall could mean they could likely be beyond the help of C-Pulse.
It is understandable if the personal Physician of such a patient still enrolled them because there was no other viable alternative to C-Pulse, and there was a chance it could help. But putting patients in the trial for whom C-Pulse is unlikely to be efficacious is highly prejudicial to the purpose of the trial.
If the selection of the patients is done well it should ensure success at the Interim Analysis. And once PMA is achieved, there is no reason for borderline patients not to be treated if that is the wish of the patient and their Physician (just not in the Pivotal trial).
talk to Sam.. let's get together Friday -- 0700 at Galleria or you can name it. Commiserate about the CC. I have 3 next week. Should be an interesting week. Will we get Garcia back ? best
Boston Scientific Corp.’s cost-cutting plans and new devices it can make more efficiently will bolster operating profit margins beyond the 25 percent goal for 2017, Chief Executive Officer Mike Mahoney said.
The maker of defibrillators and stents plans to boost adjusted operating margins by an additional 0.5 to 1 percentage point a year in 2018 and 2019, Mahoney announced at an investor day in New York. After expanding sales in 2014 for the first time in five years, Boston Scientific is aiming for revenue gains of 3 percent to 5 percent this year, excluding acquisitions, and as much as 6 percent in 2016, he said.
“We are really showing confidence in our long-term financial outlook with mid-single digit growth for the company and differentiated margin expansion,” Mahoney said in the interview. “We are growing faster than our peers in most of our businesses and we have the No. 1 or No. 2 spot in five out of seven businesses.”
Boston Scientific, with headquarters in Marlborough, Massachusetts, and sales predominantly in the U.S., is expanding abroad after moving manufacturing to locations like China to lower costs. The company intends to get 15 percent of revenue from emerging markets by 2017, up from 10 percent last year. It’s also moving its product mix toward faster-growing items including devices to prevent erratic heart rates and stroke, from more stable products such as heart stents.
Shares of Boston Scientific fell 1.6 percent to $17.54. The company suspended share repurchases for at least a year as it places a priority on debt repayment and acquisitions.
Many of the products Boston Scientific will introduce this year come with lower costs and improved engineering, Mahoney said. The company will produce an updated version of its S-ICD defibrillator, which restores electrical activity in the heart without the direct attachment of troublesome wires. It recently won approval for Watchman, a device to close off a section of the heart where blood can pool to form dea
another uneducated Mill trying to be a big boy. Sitting here waiting for the first pitch Cardinals and Pirates -- not a single dip stick would know the difference between HF and Pimples.
for the C-Pulse - then those creating the supply and then of course those potential consumer of the C-Pulse. Otherwise just a bunch of hacks gambling not unlike the lottery.
viewed by Cardiologist in treatment of HF? note the commonality of those two questions... cardiologist - now that's where you would find useful info..
and the FDA process could well be 24 - 36 months - with a lot of 'silence' in between.
C-Pulse is an Investigational device. The device is limited by Federal (or United States) Law to Investigational use only.
It is not available for sale in the United States.
ABIOMED, Inc. provides medical devices in circulatory support and continuum of care in heart recovery to acute heart failure patients. Its products consist of Impella 2.5 catheter, a percutaneous micro heart pump with integrated motor and sensors for use in interventional cardiology; Impella CP, a micro heart pump; and Impella 5.0 catheter and Impella LD, which are percutaneous micro heart pumps with integrated motors and sensors for use primarily in the heart surgery suite. The company also manufactures and sells the Impella RP, a percutaneous catheter-based axial flow pump; and AB5000 circulatory support system and the BVS 5000 biventricular support system for temporary support of acute heart failure patients in profound shock, including patients suffering from cardiogenic shock after a heart attack, post-cardiotomy cardiogenic shock, or myocarditis. In addition, it offers Symphony, a synchronized minimally invasive implantable cardiac assist device designed to treat chronic patients with moderate heart failure by improving patient hemodynamics; and AbioCor program. The company sells its products through direct sales and clinical support personnel in the United States, Canada, Germany, France, the United Kingdom, and internationally. ABIOMED, Inc. was founded in 1981 and is headquartered in Danvers, Massachusetts.
Do you not know that one needs a working heart to live? :) geez your post are often elementary. but I guess that's the life of one that has never worked in a health care facility.... and watch the NFL draft :)
If only everyone was normal - well we know something isn't normal about Bigs. Couldn't pass the MCAt
basis of such liberal use of said quote. He has a long history of this. rephrasing some fact to suit his purpose and then pretend it's a direct quote in other words his is a liar why what does he want to achieve doing such nonsense for now over 20 months on this board. OCD bi polar something
What I said - is that your quote and the quote you provided like comparing apples to oranges. :) your quote is not Cleveland Clinic quote where is the Mayo Quote dummy
ok why you could never take the MCAP and the local Community College didn't school you in English.. What does this quote ( I haven't checked to see if you just cut and paste with your own changes) nevertheless -- this quote IS NOT why you tried to say in layman's language. Your not a doc - Dr S just laughed how you take something out of context then change it... then it doesn't relate to a specific patient... your a joke..
Your correct. Should help in the enrollment! Know much better what patients 'should' benefit the most. now a ? for impt. who will the Titans take # 2.
Bigs just had a latte with my Cardiologist BJC "She' just laughed at your quote "will have their heart muscle walls continue to weaken and / or stiffen" where in the world did he get that!!!! OCD Supreme can you provide a cut and paste with quote. U know from the Cleveland clinic... :) :) :) :) where in the world did he get his MD Degree?