medmarket’s posterous

On the relative efficacy of continuous-flow left ventricular assist devices versus older, pulsatile devices...

(I posted a truncated headline and link to this item on Twitter, but admittedly the there is too much detail to fit in 140 characters.)

Although the human heart is intrinsically pulsatile, evidence suggests that a continuous-flow left ventricular assist device is more effective and safer than pulsatile devices.

From the NEJM paper, "Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device":

Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.

See link. 

(As a complete aside, one very specific limitation in LVAD, or any artificial circulation device, that my father, a general/thoracic surgeon, would point out, was the inevitable hemolysis they must cause. Whether it is the pulsatile flow or just the force of valves on red blood cells, he felt the obstacle would be an insurmountable technical challenge It has indeed proved a difficult obstacle, but technology has advanced at a pace that it may no longer be the case.)

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A group of European scientists said Wednesday they have successfully connected a robotic hand to an amputee, allowing him to feel sensations in the artificial limb and control it with his thoughts.

See more at link. 

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Options for drug-eluting stent (DES) manufacturers to differentiate their products include stent material, stent shape, drug-deposition methods and others, but most importantly the drug itself.  The first drug employed in drug-eluting stents was sirolimus in J&J's CYPHER stent, followed by Boston Scientific with its paclitaxel-coated TAXUS stent.

"Others" includes undisclosed drug on pericardium covered stent, undisclosed drug in polymer drug delivery system, “Drug Q”, AVI-5126 (CoCr), dexamethasone, dual drug (zotarolimus and dexamethasone), myolimus, novolimus, rapamycin with biodegradable polymer coating, tretinoin, Undisclosed antiproliferative, undisclosed drug (biodegradable, absorbable), and voclosporin. 

Source: MedMarket Diligence report #C245, "Worldwide Market for Coronary Stents."

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Researchers at the University of Miami Miller School of Medicine have shown that treat of heart attack patients with adult stem cells can result in repair of heart tissue damage and fewer complications:

The trial, lead by Joshua M. Hare, M.D., director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, found that the stem cell-treated patients had lower rates of side effects, such as cardiac arrhythmias. Moreover, "they had significant improvements in heart, lung and global function," Hare explained. "Echocardiography showed improved heart function, particularly in those patients with large amounts of cardiac damage."

See link for more.

The trial of 53 patients at 10 U.S. centers since 2005 was sponsored by Osiris Therapeutics and involved the use of mesenchymal stem cells.

See the forthcoming (Dec 2009) MedMarket Diligence report on Tissue Engineering & Cell Therapy, report #S520 and the 2009 report #C245 on Coronary Stents.

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With big medtech financings during the month of November by Fate Therapeutics ($30MM), Entellus Medical ($30MM), Spinal Modulation ($27MM) and Apnex Medical ($21MM), the overall month shaped up well, at over $250 million total, particularly for a month truncated by the Thanksgiving holiday.

See the individual financing numbers at link and below.

November 2009 Medtech Financings

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The continued evolution of medical technologies is making it increasingly difficult, almost moot, to distinguish a medical device from other therapeutics. In Science Translational Medicine November 30, 2009, Harvard scientists report on the use of a polymer disc that stimulates an immune response that in turn shrinks tumors:

In a new approach to fighting cancer, scientists from Harvard University have engineered an implantable disc designed to attract immune cells and prep them to attack tumors. Mice with melanoma tumors were much more likely to survive if they’d been implanted with the device, and tumors disappeared in up to half of the vaccinated animals, according to research published today in the journal Science Translational Medicine. Researchers believe that the implant elicits a broader immune response than traditional vaccines, and may therefore prove more effective. A startup called InCytu, based in Lincoln, RI, is now developing the technology for human testing.

One might call this a device for the fact that it is implanted, but the response it engenders is more a drug delivery, which would indeed be a device except for the fact that this device does not delivery drugs. One might also consider that this could be viewed as a drug -- a solid drug -- except for the fact that it is not metabolized like a drug. It could be considered gene therapy, since the polymer contains fragments of genetic material designed to mimic bacterial DNA. It could be considered an autologous cell therapy treatment, since the polymer also contains fragments of the patient's own tumor. As far as I am concerned, the definition is moot, since the principal criteria for judging the implant is its safety and efficacy in treating tumors. The most important consideration here is that, as evidenced by this definitional challenge, there is a merger of multiple scientific disciplines taking place that is resulting in very unique therapeutics. The advances in cell biology, materials technology, gene therapy, chemistry and other sciences are proceeding rapidly and synergistically to yield products that will most importantly challenge the device industry AND the drug industry (and many others) by producing results that compete with any and all of them.

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Advances at Tel Aviv University in development of bioabsorbable materials for use in coronary stents are discussed:

http://www.lifesciencesworld.com/news/view/125802

The ability to control both drug-elution rate and the time to bioabsorption by the body make these developments noteworthy for their potential to rapidly bring these new coronary stent options to market.  Such control will allow developers to optimize the performance of stents in the goal of revascularization and anti-restenosis.

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See also MedMarket Diligence report #C245. 

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In the course of a week, two separate surveys of the medtech industry have confirmed that executives foresee business in 2010 moving positively, but without an abundance of optimism -- or effort.

The Emergo Group survey of 1,000 medtech executives illustrated results similar to the smaller, anecdotal Tatum LLC, survey, which indicated that, in 2010, execs expect sales to increase, modestly, and hiring to increase only just modestly.

Overall, the industry sees growth happening less as a result of the actions they initiate (aside from the Emergo Group's survey indicating international market expansion into Brazil, China, Europe and India, in that order) than an apparent expectation of a turn in the economy and little else.

The past year has been a period of passive activity for the industry, starting with the credit crunch limiting investment, followed by the economy going negative causing most spending to be put on hold and capped off by the advent of healthcare reform and an impending device industry tax. Perhaps it shouldn't be surprising, then, that the industry expects even a modest reversal of fortune to take place without their active involvement.

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Three-year data from a trial of 30 patients implanted with a bioabsorbable, drug-eluting coronary stent from Abbott are showing the promise of this alternative stent technology, according to a press release from the company.

Abbott's bioabsorbable coronary stent is an everolimus-coated coronary scaffold is made of polylactide, the same material used in absorbable sutures.  According to Medgadget and an Abbott press release:

The ABSORB trial is a prospective, non-randomized (open label), two-phase study designed to enroll approximately 130 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety - MACE and stent thrombosis rates - at 30 days; six, nine, 12 and 18 months; and two years, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six months, one year and two years.

The $7.4 billion global coronary stent market is dominated by $4.7 billion in drug-eluting stent sales, but as bioabsorbable stents emerge and are introduced to the market, expected as early as 2012, the market is expected to shift toward bioabsorable stents, which will putatively minimize long(er) term risks like late stage thrombosis.

MedMarket Diligence has published its report, "Worldwide Coronary Stents, 2008-2017",  report #C245.

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A recent survey of medical technology industry executives by Atlanta-based executive services firm Tatum LLC, as reported in The Journal of New England Technology, revealed a tone of "cautious optimism" among the group as they looked out over the next couple months:

Almost two-thirds of those executives surveyed — 40 in total — said they expected their business to improve overall in the next 60 days. More than one-third thought financing conditions would improve during the same time period, and one-third expected to make hires in the next 60 days.

The caution expressed in the survey is evident in the fact the three quarters of respondents indicated that they did not expect to increase their capital expenditures during this time, nor did many surveyed indicate an intention to increase inventories.

An apparent pall may have lifted that had been hanging over the industry in September/October, when economic indicators had not shown even the tepid suggestion of growth that exists now, the stock market had not quite yet shown its anticipatory surge in prices (with the Dow since crossing and staying above 10,000) and there seemed to be few prospects of even a contentious healthcare reform bill (or one without a prohibitory device industry tax) passing by year end.  All of that has has changed, though not in a way that has accomplished anything more than a tip toward optimism, as reflected in the survey.

The industry, through the remaining 4Q 2009 and into 2010, faces:

• real uncertainty about the short- or medium-term impact of healthcare reform legislation
• slow economic growth that will put constraints on investment, hiring and capital expenditures
• a continued fallout of medtech startups and development stage companies, adding to the list of those who have succumbed to the financing pinch (see WSJ "Turning Out the Lights") with only a few noteworthy successes (gauged by follow-on investment or even acquisition)

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