BB&T

Making a surgical incision to reach areas with the abdomen has always been the most practical method of entry — or at least the most common. But more surgeons are using alternatives to this conventional method, by accessing the body's natural openings as pathways that may be less problematic for the patient, providing quicker recovery and leaving no observable scars.

In an era in which speed is weighted as almost equal to quality, surgeons are beginninng to use the mouth as a primary pont of entry.

Steven Gorcey, MD, division chief of gastroenterology at Monmouth Medical Center (Long Branch, New Jersey) and Frank Borao, MD, chief of minimally invasive surgery and medical director of Monmouth's bariatric surgery program, recently used this pathway to do a procedure that helps patients lose the weight they've regained after gastric bypass.

The incision-free procedure, which surgeons have dubbed ROSE (restorative obesity surgery, endolumenal), reduces the size of the stomach pouch and stoma to the original post-gastric bypass proportions to help the patient lose the regained weight.

"The benefit [of going through the mouth] is a quicker recovery time," Borao told Biomedical Business & Technology. "Patients go home immediately. The only thing they suffer from is a mild sore throat — and that's it."

An estimated 44% of patients who undergo gastric bypass regain weight — and the dangerous co-morbidities associated with that weight — a few years after their initial operation. Studies indicate that post-gastric bypass weight is regained sometimes because the stomach pouch and the opening to the small intestine (the stoma) slowly stretch out, enabling the patient to eat more without feeling full.

Invasive procedures to restore the anatomy to the original post-surgery proportions have been too complicated and dangerous for most patients, leaving them without feasible treatment options, but with much of the weight they thought they had lost.

In the procedure, Borao used a small flexible endoscope and a new EndoSurgical Operating System (EOS) developed by USGI Medical (San Clemente, California), specializing in instrumentation for these kinds of procedures, inserted through the mouth into the stomach pouch. Tissue anchors are used to create multiple, circumferential tissue folds around the stoma to reduce its diameter. The surgeon then uses the same technique to place anchors in the stomach pouch to reduce its volume capacity.

Hooks and graspers such as these are characteristic of these instruments and they are being combined with robotic manipulation to become even more sophisticated in what they can do.

"The idea is that a device should be able to operate like an endoscope," Chris Magee, director of marketing for USGI, told BB&T.

"EOS is a four-channel device, with one channel reserved for visualization and the other three for channels holding tools." EOS received FDA approval in September 2007, that the comand Magee said that the company is currently seeking the CE mark. He added that the device also is being marketed as a platform system usable for other procedures.

The procedure is part of a growing trend in the use of medical devices, called natural-orifice translumenal surgeries, or NOTES, using the natural passageways of the body to avoid external incisions, and, it is hoped, to reduce the chance of infection.

Other reported NOTES procedures have included removal of gall bladders and cancerous tumors.

On the horizon are more complex procedures, such as resections of fallopian tubes, bypass procedures and the draining of coronary arteries. These are being performed primarily in preclinical trials. As this research work moves forward, it is producing a wealth of patent filngs.

But the field is not without controversy. While NOTES proponents tend to call it incision-less, the procedure usually requires incisions inside the body.

Controversy or not, the strategy is sure to grow as more procedures of this type are performed and word spreads among patients hungry for procedures billed as "minimally invasive."

Last month, surgeons at UC San Diego Medical Center reported performing what they said they believe is the country's first removal of a diseased appendix through the mouth. This clinical trial procedure received approval for a limited number of patients by UC San Diego's Institutional Review Board (IRB) which oversees clinical research.

"The purpose of this clinical trial is to test more 'patient-focused' techniques for minimally invasive surgery," Mark Talamini, MD, professor and chair of the department of surgery at UC San Diego Medical Center, said in a statement. "[We are] testing groundbreaking ways in which to perform surgery with fewer incisions, less pain and more rapid recoveries."

Santiago Horgan, MD, professor and director of UC San Diego's Center for the Future of Surgery, and Talamini, president-elect of the Society of American Gastrointestinal and Endoscopic Surgeons (Los Angeles), performed the surgery on a 42-year-old man. The center said it is first U.S. hospital to perform the procedure, with India being the only other country to report such an operation.

"Only one small incision to insert a small camera in the bellybutton was required to complete the surgery, vs. three incisions required for a laparoscopic procedure," said Horgan. "The patient was discharged 20 hours after surgery and is now reporting minimal pain, which is a goal for all of our patients."

Magee, who was aware of the USGI procedure, said the center is at the beginning of a wave of an emerging market. "There is no shortage of interest in this procedure," he said. "We're seeing patients and surgeons genuinely interested in this."

InHealth sets $10M goal for device/diagnostics research

The Institute for Health Technology Studies (InHealth; Washington) has launched a new capital campaign to raise up to $10 million in funding to advance its mission of sponsoring evidence-based research on the value and impact of medical devices and diagnostics. The campaign, to extend through 2009, was reported at the recent 2008 annual meeting of the AdvMed (Washington).

The campaign's "quiet phase" already has secured $4.2 million in pledges. Donors include original funders Johnson & Johnson (New Brunswick, New Jersey); Stryker (Kalamazoo, Michigan); St. Jude Medical (St. Paul, Minnesota); the C.R. Bard Foundation (Murray Hill, New Jersey); BD (Franklin Lanes, New Jersey) and the Edwards Lifesciences Fund (Irvine, California).

InHealth was founded with unrestricted donations from leaders of the medical technology industry, focused on establishing an independent, non-profit organization to fund objective, peer-review quality research and analysis on the impact and value of medical technology.

Donors may channel their pledges to areas of interest that correspond to industry sectors, such as cardiovascular, orthopedic, wound care, diagnostic imaging, in vitro and molecular diagnostics.

In 2008, InHealth will award at least five new research grants totaling up to $1.5 million and organize new educational forums. This spring, InHealth will launch the next generation of its web site, designed to bring together an interactive community of those with an interest in medical technology innovation and provide real-time news, research and information on its impact.

Ensysce stems from the final research interests of the late Dr. Richard Smalley, the 1996 Nobel Laureate for Chemistry from Rice University (Houston), a pioneer in considering the therapeutic potential of carbon nanotubes. Unidym acquired rights to Smalley's work in carbon nanotechnology through a corporate merger last April.

New ventures

Cambridge offers wireless tech to firms for under $10

While many companies can claim to be working on developing wireless technologies for incorporation into medical devices, none have offered to allow a manufacturer to incorporate the technology into their products at a potential cost of less than $10 a unit. Until now.

Cambridge Consultants (Cambridge, UK/Cambridge, Massachusetts) says it now can alter this paradigm with a "breakthrough software solution," the Vena platform comprised of a single chip designed to allow devices, such as pressure monitors, to transmit data wirelessly.

Cambridge said this gives consumers, especially those with chronic conditions, the ability to monitor their own health accurately and independently. The platform uses low-cost wireless technology allowing devices to deliver medical readings to a central monitor in the home or to an online health record such as Google Health or Microsoft Health Vault.

Paul Williamson, head of wireless medical at Cambridge, told Biomedical Business & Technology that the $10 price point will attract many buyers to the technology. "We think that's quite an attractive price point from a materials point of view." He said that past generations of wireless technology have been relatively expensive due to a lack of industry standards for such technology, making it for the most part proprietary and thus expensive, or, as he put it, "low-volume and high-cost."

The Vena platform takes advantage of high-volume Bluetooth technology, and Cambridge noted that it embeds both the emerging IEEE11073 standard, which ensures compatibility of data exchanged between different types of devices, and the emerging Bluetooth Medical Device Profile, which has been optimized for the secure transport of medical data, onto the single chip. IEEE11073 Personal Health Data is a framework of standards that addresses transport-independent application and information profiles between personal telehealth devices and monitors/managers (e.g., health appliance, set-top box, cell phone, personal computer). Device profiles include pulse oximeter, blood pressure monitor, weighing scale and thermometer.

Because Bluetooth technology is so cheap, Williamson said that the company can provide "a low-cost consumer price point for the platform hardware." Williamson said the platform also offers unique "compatibility and interoperability to the table — an important factor in the medical device arena."

Williamson said that, in general, a manufacturer producing a device only owns one end of the system and wants it to be able to interoperate, "so what the combination of the Bluetooth profile, which is one standard, and the IEEE standards, which define the way different devices behave, brings to the table is that compatibility."

The Vena platform can be used with multiple devices providing a connection to online records through a monitoring station, home PC or set-top box. In addition to Bluetooth, the platform incorporates complete support for a range of other connections. Full TCP (Transmission Control Protocol) implementation allows wi-fi or ethernet connections. Cable connections via UART (Universal Asynchronous Receiver/Transmitter) or USB also can be added. The platform can even be used to transmit data via mobile phone for health and fitness applications on the move.

Since the platform incorporates Bluetooth, Williamson also noted that the system did not require any modifications from its European iteration for use in the U.S. "[Bluetooth] operates in an internationally license-free band, which means you can produce a single device which will operate in multiple geographies."

Williamson emphasized ed that the Bluetooth Medical Device Profile and the IEEE are still emerging standards, but the company is telling manufacturers that the platform is available and may become a de rigueur component to add to a product in the near future.

"We believe that device manufacturers will want to design in the [platform] effectively pre-emptively so that as soon as this technology is available and ready to go, they will already have incorporated it."

• BioTime and its subsidiary Embryome Sciences (both Emeryville, California) have signed a letter of intent with International Stem Cell (Oceanside, California) and its subsidiary, Lifeline Cell Technology (Walkersville, Maryland), to jointly produce and distribute an array of research products from human embryonic stem (hES) cell technology.

According to the companies, hES cells have the potential to become all of the thousands of cell types in the human body and provide a pathway to regenerative medicine. Embryome Sciences and Lifeline said they will jointly manufacture products serving the needs of this industry, including cells and related products enabling researchers to identify and study the thousands of cell types that can be made from hES cells.

Michael West, PhD, CEO of BioTime and Embryome Sciences, said, "While many have focused on the therapeutic opportunities of hES cells, and the generous $3 billion of funding provided by the State of California to fund this research, it is important to remember that the people who really profited from the California gold rush of the 19th century were the makers and suppliers of the tools.

"While not ruling out entering the therapeutics race at some point, we believe that the greatest rate of return on investment may be in commercializing research products that can be produced and marketed within one to two years. We intend to win the race to profitability in this important field of medicine."

The parties intend to manufacture ESpy cell lines (derivatives of hES cells that send beacons of light in response to the activation of particular genes), as well as various supplies that scientists can utilize in stem cell research. The progenitor cell lines will be produced and distributed in joint efforts utilizing Embryome Sciences' proprietary "Embryomics" technology, its future Embryome.com online database, and technology and approved hES cell lines licensed from the Wisconsin Alumni Research Foundation (Madison, Wisconsin).

Lifeline will contribute manufacturing and quality control expertise backed by a staff with over 150 years of experience in the field, its facilities and technologies. The collaboration is subject to the execution of a definitive agreement.

BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic, surgery, organ preservation solutions, and technology for use in surgery, emergency trauma treatment and other applications.