FDA Approves Adhesion Prevention Solution for Surgery

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The FDA recently approved Adept from Innovate PLC (formerly ML Labs) as an adhesion prevention agent following gynecologic laparoscopic surgery.  I know this product well as I was involved in the original US Pilot study in 2001.  There are few products approved for this use at open surgery but none before have been approved for laparoscopic surgery.  Many have tried and failed!  Adaept is essentially a starch based solution (4% Icodextrin) that is placed in the abdominal and pelvic cavity during surgery.  It works via osmotic gradients to pull water into the pelvic cavity.  This is the old “hydroflotation” strategy whereby fluid causes cut structures to float away from each other and not adhere during healing.  This concept was originally developed with plain ringer’s solution then replaced with Hyskon.  Resuts were very minimal when these were fianlly tested (despite years of use).

 Adept was originally developed for use in peritoneal dialysis. The US trials for approval for use in surgery demonstrated a reduction in the number of adhesions when it was used versus controls.  Adept 45% with a decrease in scar sites versus 35% in the control arm.  Interestingly, for the two other main outcomes of efficacy Adept failed to meet significance.  The FDA panel voted to approve it nonetheless in view of its excellent safet record and use outside the USA since 1999 with minimal adverse effects.  Actual efficacy is however less than I would have liked to see in this study. 

Other devices available currently in the market include Interceed from J&J (not approved for laparoscopic use) and Seprafilm (not approved for laparoscopic use– potentially better but a NIGHTMARE to use at laparoscopy since it sticks to everything then disolves.

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Veinviewer Sees Veins Under Skin For Simpler Blooddraw

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The Wired Nextfest is currently underway in NYC (report and photos coming!).   One product featured is the VeinViewer from Luminetx.  This amazing device uses near infrared light to image blood vessels under the skin’s surface.  A projector then projects an image onto the skin providing a roadmap for blood-draws that will eliminate the need for multiple pokes and fishing around.  Not only a very needed development for phlebotomy it has implications for future disease detection and vascular therapies.  A biometric device (Snowflake) is also under development which maps and idividual’s unique vein patterns for ID. 

I am very interested in the development of alternative and future imaging devices.  Augmented reality will be breakthrough technology in the future of medicine and this is one of the first applications commercialized.  Many modalities of energy can be coupled to this to target the vascular system.  Combinations with HMD’s or integrated OR’s allow incorporation  into the OR.  Once this technology enters the OR the potenetial for intrabdominal or internal organ use opens up and ultimately it could be incorporated into remote self-contained internal robotic devices…

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Docinthemachine Links Begin!

After just a week the links to docinthemachine have started!  Both the haptics newslog and medgadget.com have linked to us.  If you are not familiar with these sites check them out.  Haptics newslog is an in depth review of all applications of haptics and medgadget is a leading overview of all breaking news in medical gadgets as they are released.

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HD endoscopy system in regular use

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We have now implemented the Stryker 1088 HD system into regular use for laparoscopic and hysteroscopic procedures.  Housed in an integrated OR there are three flat panel LCD screens, all components are boom mounted and all video goes through a central bus.  I performed the world’s first HD laparoscopy 6 years ago and it’s great to see these systems commericalized after such a long wait.  IN upcoming days I’ll print in depth reviiews of this new system as well as others that I have been fortunate to have tested while in development.  In short this system is very nice but does not deliver the resolution and benefits of HD expected.  Further testing will determine if the fault lies in the panels or the camera.  One striking difference between this and the first prototypes we tested in 2000 (developed by JVC for microscopy originally) is that that true 1080i system yielded a pseudo 3-D depth perception as a result of the high resolution.  This phenom is readily sen on high quality HDTV’s and was also visible in the large format broadcast I did at the 2000 AAGL meeting.  More to come but HD continues to push the visual info available for endoscopic surgery.

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Human Life Extension Not Here Yet But Hibernation May Be!

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There have been lots of posts lately about the $3.5M pledge from Peter A. Thiel, co-founder and former CEO of PayPal to the anti-aging research Methuselah Foundation.  Here today mamalian hibernation may be able to be triggered with hydrogen sulfide gas.  It is unclear if this state can last for years but it does seem as if it could be applied to humans (subjects invited).  Mark B. Roth of the Fred Hutchinson Cancer Research Center reported in Science that the induced hibernation state had enormous slowing of all metabolism and biological activities– suspended animation may be closer than we think. 

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“Living Chips” Enable Nextgen Diagnosis/treatment

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A University of Rochester Cardiologist is working to refine “biochips” — the promise lies in implantable devices working in synergy with human tissue to provide disease testing and monitoring.  Yet another installment in the implantbale future of medicine.

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Pill-Cams Take New Diagnostic Turn- Possibilities are Endless!

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Recently approved by the FDA, SmartPill is the next generation of swallowable GI diagnostics.  I have been involved as an MD in miniaturized endoscopy for some time.  This is an important advancement since it is the first time the sensor has moved beyond visual imaging to other diagnostics.  The swallowable pill technology is not new.  Originally developed by NASA to measure core temperature of astronauts (I used this capsule in research on menopausal hot flashes 10 years ago).  The next major breakthrough was by Israeli company Given Imaging who put a small video camera and location system to provide images of GI pathology.  SmartPill sets the sage for endless diagnostics and therapeutics in addition to video.  See our posts about self propelled devices for other body cavities earlier.  

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SLS Update 3: Krazy Glue Tissue Sealant Blocks Healing

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Krazy Glue-type tissue adhesives have been hot in development for some time.  Lots of promise and huge expectations but they have not worked so well and have had poor market penetration.  They have been primarily used ofr small laceration and insision closures.  The hype has been to use them for more complex repairs and replace sutures staples etc. This presentation showed that in a hernia repair model with mesh these tissue sealants clearly impaired tissue healing.  This has 100% been my experience with their use.  I see that the tissues adhere but the glues seem to block the normal tissue to tissue attachment and ingrowth of vessels and fibroblasts etc. The author was Alexander Petter-Puchner,MD who was awarded the best paper -General Surgery for this study.

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Sprayable Polymer System- Antiadhesion Now But in the Future… (video)

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see video of application

Spraygel is a sprayable polymer based system for adhesion prevention.  Approved outside the USA its US trial has been delayed over a bumpy road.  The system works by taking 2 liquids sprayed into the abdominal cavity at laparoscopy.  The liquids react forming a PEG hydrogel.  Think of foam spray insulation.  The stuff makes a coating on organ surfaces preventing scar tissue formation.  What’s more exciting is the potential to combine this with a drug delivery system

See dental development post below for another idea on this. 

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