USGI Medical's (San Clemente, California) Incisionless Operating Platform (IOP) could become the device of choice for surgeons seeking to correct a failed vertical banded gastroplasty.

The IOP has been used for procedures designed to reduce the size of the stomach pouch and opening to the small intestine in patients who developed pouch or stoma dilatation post-Roux en Y gastric bypass (RYGB).

To perform these surgeries a small flexible endoscope and an IOP are used. The devices go entirely through the patient's mouth. The IOP tools are used to grasp tissue and deploy suture anchors to create multiple tissue folds in the stomach pouch, allowing the surgeon to reduce the volume to more closely match original VBG proportions.

The procedure is similar to ROSE (Revision Obesity Surgery, Endolumenal), a procedure to "tune up" the anatomy in roux-en-Y gastric bypass patients who've started regaining weight.

"Basically what the device allows us to do is endoscopically go down and arrange some tissue fasteners (pleats) in the stomach pouch," Dr. Peter Henderson MD, of Georgia Coast Surgical (Brunswick, New Jersey), told Biomedical Business & Technology. The really nice thing about this whole approach, you're able to do this without entering the abdominal cavity . . . all done endoluminally. Patients can go home to the same day; they don't have a lot they have to heal up from."

Henderson added that by eliminating skin incisions and the tedious dissection of scar tissue in the abdomen, this new incisionless approach reduces the risk of a traditional VBG revision.

IOP was developed in house and received FDA approval in 2007. The device is currently in the process of receiving CE-mark approval in Europe. It could possibly receive this approval in six months, the company said.

Here's how the device works:

Combining the incisionless nature of endoscopy with the therapeutic benefit of laparoscopy, the IOP delivers USGI's expandable tissue anchors. These anchors were designed to address the challenges of endolumenal wound closure. The expandable tissue anchors spread forces to allow improved tissue healing and surgical feel while tensioning the sutures.

To date the device has received a great amount of publicity and is gaining traction. IOP was featured in three podium sessions at the recent Society of American Gastroenterological and Endoscopic Surgeons (SAGES; Los Angeles) scientific session in Phoenix.

Surgical teams at UC San Diego, Legacy Health System (Portland, Oregon) and Hospital Bocalandro (Buenos Aires, Argentina) used the IOP to perform multiple common surgical procedures using four separate incisionless surgical approaches.

Surgeons also have used the IOP to perform nine cholecystectomies (gall bladder surgeries), two appendectomies; and 18 endolumenal gastric pouch and stoma reductions in post-Roux-En-Y gastric bypass (RYGB) patients.

Elsewhere in the product pipeline:

Abbott Laboratories (Abbott Park, Illinois) reported the launch of two new products for the treatment of peripheral artery disease (PAD), a condition that occurs when the vessels supplying blood to the legs, arms, stomach or kidneys become narrowed or blocked by plaque, restricting normal blood flow. The FoxCross PTA catheter is a next-generation .035 balloon dilatation catheter, and the Hi-Torque Versacore .035 Guide Wire is a peripheral guide wire for delivery of catheters, balloons and stents. The FoxCross PTA is available in a wide variety of diameters (3 mm to 14 mm), balloon lengths (20 mm to 120 mm), and catheter lengths (50 cm, 80 cm and 135 cm) on an over-the-wire delivery platform. The Hi-Torque features a soft, shapeable tip to provide safe access to peripheral lesions and enhanced visibility under fluoroscopy.

AdvanDx (Woburn, Massachusetts) reported FDA clearance for EK/P. aeruginosa PNA FISH to identify Escherichia coli and/or K. pneumoniae as well as Pseudomonas aeruginosa directly from positive blood cultures. The company says that EK/P. aeruginosa PNA FISH is the first-ever test capable of identifying E. coli and/or K. pneumoniae and P. aeruginosa directly from positive blood cultures and that the PNA FISH tests now provide rapid, therapy-guiding results for 95-99% of patients with bloodstream infections and positive blood cultures. PNA FISH is a sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don't require the extensive sample preparation necessary for other nucleic acid technologies.

Alphatec Holdings (Carlsbad, California) has introduced the ARC Portal Access system in conjunction with the introduction of the minimally invasive GLIF (Guided Lateral Interbody Fusion) technique. The GLIF technique and ARC Portal Access System is designed to allow surgeons to perform lumbar interbody fusion procedures with the opportunity for less intra-operative blood loss and minimized tissue disruption; while decreasing the recovery time for most patients. The ARC system and instrumentation has been designed specifically for the GLIF technique, providing lateral access with direct visualization to the intervertebral disc space while allowing the patient to remain in a prone position. When augmented with posterior pedicle fixation, the ARC system eliminates the need to reposition the patient intra-operatively, thereby reducing the overall length of the lateral lumbar fusion procedure and potentially reducing operating room costs.

Clarient (Aliso Viejo, California) has introduced a new breast cancer test that helps physicians identify the probability of a patient's cancer recurring and assess the need for chemotherapy. The new prognostic test, Insight Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor-positive breast cancer. The Insight Dx Breast Cancer Profile combines three traditional pathology staging risk factors with seven key molecular markers. Staging factors are tumor size, tumor grade, and lymph node status. Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC.

• Preliminary data presented at the SCAI Scientific Sessions show that 82% of patients treated with Cook Medical's (Bloomington, Indiana) Zilver PTX drug-eluting peripheral stent were free from reintervention at two-year follow up. The ongoing Zilver PTX Registry study is assessing the safety and efficacy of the Zilver PTX in treating PAD. In many cases, PAD patients who have been treated with balloon angioplasty and stenting experience restenosis, or renarrowing of the arteries, over time and must undergo more invasive treatment such as bypass surgery to restore blood flow to key arteries. The Zilver PTX self-expanding nitinol stent uses a proprietary, polymer-free technology to coat the device with paclitaxel, an antiproliferative drug that has been used successfully to reduce the risk of renarrowing of arteries following angioplasty in coronary disease patients.

DxNA (St. George, Utah) said that it is developing a diagnostic test for its GeneSTAT pathogen detection platform to detect the swine flu virus in roughly 45 minutes, using a device weighing less than 10 pounds. The Company said it anticipates having a product ready for evaluation in one to two weeks. The GeneSTAT platform includes a device that offers portability and remote usage to rapidly detect pathogen outbreaks. The device also is suitable for use in gateway airports, at health departments and schools, where on-site, rapid and non-invasive screening is advised. The GeneSTAT test module requires only a swab of the mouth, nose or throat. The company said it is developing follow-on tests to detect pathogens that may affect people and agriculture.

Energex Systems (Allendale, New Jersey) said it has notified the FDA of its interest in applying for an Emergency Use Approval that would permit the company to offer its HemoModulation therapy for the treatment of type A, H1N1 swine flu. It said that HemoModulation therapy has been shown to inactivate the virus in mice. This same therapy has been under review by the FDA and is in human clinical trials for hepatitis C and HIV. HemoModulation therapy uses UVC energy to inactivate the particular strain of virus that the patient is infected with, and returning to the body. The hypothesis is that UV inactivated virus will serve as an autologous vaccine and boost immune systems against their particular strain of virus. The process takes about 30 minutes and can be administered in an office or lab.

Entellus Medical (Minneapolis) reported the first enrollment in the FinESS Registry, a prospective, post-approval registry study designed to assess subject rhinosinusitis symptomatic status of up to 500 patients treated with FinESS Sinus Treatment over time. The objective of the Registry is to assess subject rhinosinusitis symptomatic status at pre-treatment, six months and twelve months post-treatment following FinESS Sinus Treatment using data collected from validated, self-administered QoL (quality of life) surveys. FinESS Sinus Treatment is a less-invasive treatment option to break the cycle of chronic rhinosinusitis. It is for patients whose symptoms persist or return, despite antibiotics and steroids or for patients who do not need, want or can't have extensive sinus surgery.

Evogen (Kansas City, Missouri) said it is developing multi-faceted capabilities to address the air-monitoring, detection and diagnosis of Influenza A H1N1, or Swine Flu, in addition to several prevalent flu types. Evogen's molecular PCR diagnostic test is capable of rapidly and specifically detecting H1N1 pandemic Influenza, using HyBeacons technology. The test can be implemented on PCR equipment currently used in laboratories globally or can be operated on Evogen's EvoCycler HD12 – which provides high-definition PCR results in a simple-to-use molecular diagnostic system that can be implemented at the "front line" in this global pandemic.

Excelsior Medical (Neptune, New Jersey) has received FDA clearance to sell its SwabCap Luer Access Valve Disinfection Cap. SwabCap is designed to assist the caregiver and protect the patient by disinfecting their swabable luer access valve prior to line access and maintaining antiseptic conditions between line accesses — all in a passive, uniform manner. Excelsior says the thread cover design makes SwabCap an effective cleaning alternative, disinfecting the valve after five minutes of application and acting as a physical barrier to contamination for up to 96 hours under normal conditions if not removed.

• Eight studies presented at the recent annual meeting of the American Urological Association suggest that and investigational test from Gen-Probe (San Diego) for the prostate cancer gene PCA3 may help challenges faced when diagnosing prostate cancer, such as accurately identification of aggressive cancers while minimizing false positive results that lead to overtreatment. PCA3 is a gene that is highly over-expressed in more than 90% of prostate tumors, indicating that it as a biomarker for prostate cancer. Gen-Probe said that studies have shown that because PCA3 is specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen tests.

Incisive Surgical (Minneapolis) said it will launch a "significantly more user-friendly" version of its Insorb absorbable skin stapler. The Insorb|25 skin stapler places an absorbable staple underneath the skin to close surgical incisions. A surgical site infection (SSI) study will be presented by the company reviewing the experience of two community hospitals using the Insorb stapler in 877 consecutive cesarean sections resulting in an overall SSI rate of 0.8% which the authors stated "compares favorably to SSI rates in similar studies of cesarean section incisions with conventional closure modalities."

InformMed (Peoria, Illinois) reported the release of its evidenced-based decision support system designed to assure point-of-care medication safety and to assist in eliminating harmful medication errors. Based on the pac2 system, the solution called ally is designed to empower nurses as the last line of defense in the medication delivery process. ally backs front line nurses when and where they need accurate dosing and medication information. "Providing solutions that can help our hospital partners deliver safer healthcare to their communities is our single minded focus at InformMed. The ally system not only expands the breadth of support for nurses at the bedside, but it also captures critical dose calculated volume information that is essential for a comprehensive EMR," said CEO Gary Conkright.

Instrumentation Laboratory (IL; Bedford, Massachusetts) said it received FDA clearance for the ACL AcuStar Hemostasis Testing system. IL says the ACL AcuStar is the first specialty-test analyzer that offers full automation of highly sensitive immunoassays for the hemostasis lab. Labor-intensive specialty tests that previously required specialized training and up to two hours to perform, can now be performed in as little as 25 minutes, with no special training required. The AcuStar uses chemiluminescence technology, broadly considered the most accurate and sensitive method for routine immunoassay testing.

Medtronic (Minneapolis) reported completion of enrollment in its investigational device exemption (IDE) study of the Endurant Stent Graft System, which is designed to enable the non-surgical repair of aortic aneurysms. Designed to evaluate the safety and effectiveness of the Endurant Stent Graft System for the endovascular aortic repair of abdominal aneurysms, the U.S. Endurant IDE study was enrolled two months ahead of schedule, having started in 2008 and involving 30 sites.

NiTi Surgical Solutions (Chesterfield, Missouri) reported the launch of ColonRing – its closure technology for colorectal surgery. NiTi says the ColonRing with BioDynamix Anastomosis technology is a novel device intended to address the major drawbacks of circular staples. Because anastomosis (the surgical connection of two parts of a hollow organ) with the ColonRing is staple-free, there are no bowel wall punctures, no risk of staple line bleeding, and no permanent foreign bodies in the bowel. In the ColonRing, the Nitinol leaf springs stretch to open the ring for placement in the bowel, and then gradually return to their original closed position, adapting to variations in tissue thickness and accommodating compressed tissue. The Nitinol leaf springs continuously apply constant force range of pressure around the full circumference of the anastomosis. As the compression progresses over several days, the tissue trapped within the ring becomes necrotic, while healthy tissue is generated along the ring's outer perimeter.

Orthofix International (Boston) said it has begun the limited market release of Trinity Evolution in collaboration with the Musculoskeletal Transplant Foundation (MTF). Trinity Evolution is a stem cell-based bone growth matrix designed to advance the surgical use of allografts by providing characteristics similar to an autograft in spinal and orthopedic procedures. Trinity Evolution is used by surgeons to facilitate bone fusion, and will be marketed exclusively by Orthofix Spinal Implants and Orthofix Orthopedics. MTF is responsible for the recovery of donor tissue, the processing of the bone growth matrix, and for the fulfilment of orders received.

PEAK Surgical (Palo Alto, California) has released results from a pre-clinical study demonstrating that the use of its PEAK PlasmaBlade is associated with improved fascia incision healing in an in vivo model compared to the use of traditional electrosurgery. Overall, the PlasmaBlade demonstrated reductions in acute thermal injury depth, healed fascial scar width and inflammatory response with greater healed wound strength. The PEAK PlasmaBlade is a family of disposable, low-temperature surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage.

Positron (Indianapolis) received FDA approval for the Attrius Positron Emission Tomography (PET) scanner product line developed by the company and its joint venture with Neusoft Medical Systems (Shenyang, China). Positron's Attrius product line was developed to provide physicians a cardiac PET molecular imaging system. The Attrius scanner comes complete with a feature set designed specifically for cardiac perfusion imaging such as a coronary artery disease software suite that includes; mercator projections, normal database comparison, coronary artery tree and distribution overlay map, rapid segmented attenuation correction, motion correction, and open acquisition architecture for today's challenging quantitative flow reserve imaging. Positron specializes in cardiac nuclear medicine.

Spectranetics (Colorado Springs, Colorado) reported initial data from the four-year, retrospective LExICon (Lead Extraction in Contemporary Settings) study demonstrating the safety and efficacy of laser assisted lead removal using the Spectranetics laser sheath. The Spectranetics laser sheath uses low temperature ultraviolet light to safely, effectively and efficiently ablate scar tissue holding problematic leads in place.

St. Jude Medical (St. Paul, Minnesota) reported the U.S. launch of its Attune Flexible Adjustable Annuloplasty Ring for the repair of diseased heart valves. The Attune ring is a flexible annuloplasty ring designed to support a repair of the heart's mitral valve. The ring's flexibility allows the annulus to continue its natural movement as the valve opens and closes, thus contributing to more physiologic valve function. The ability to adjust the ring post-implant promotes ideal leaflet alignment to reduce or eliminate residual regurgitation, or small leaks after the repair.

Urologix (Minneapolis) has presented data on the effectiveness of Cooled ThermoTherapy. This data marks the first time Urologix has presented data on tailored treatments. Tailored treatment refers to the ability of urologists to modulate the temperature of the system for optimization of patient comfort while still delivering a clinically significant high energy Cooled ThermoTherapy treatment. The data shows improvement in both the symptomatic and obstructive components of Benign Prostatic Hyperplasia (BPH), also referred to as enlarged prostate disease. Anecdotal reports have shown that many physicians modify the urethral temperature set point from the default setting to positively impact patient comfort during the procedure. Patented thermal modeling, confirmed by actual measurements, shows these reduced settings achieved temperatures in the enlarged prostate sufficient to trigger consistent destruction of cells.