BB&T Staff Writer and Staff Reports

Physicians could have a new way of measuring the effectiveness of cancer therapeutics, thanks in part to an application developed by VisualSonics (Toronto).

The Sonosite (Bothell, Washington) subsidiary unveiled its Vevo Lazr Photoacoustics Imaging system at the American Association of Cancer Research's (AACR; Philadelphia) annual conference held in Orlando, Florida.

The firm said that the device could give physicians the ability to see the effect that a drug is having on the tumor growth, which is an invaluable asset in the development of cancer therapeutics.

In practical terms, this means researchers will be able to observe tumor biology in a living host organism (mice and rats) without having to biopsy the actual tumor itself. Currently, researchers are often required to rely on ex vivo techniques such as histology and immunohistochemistry to obtain molecular information inside a tumor. The in vivo approach reduces the amount of animals required for research studies by allowing the same animal to be followed throughout the disease development and treatment. This is all made possible through a process called photoacoustics.

“Photoacoustics is a brand new imaging modality that combines the sensitivity of optical imaging to the high resolution and high anatomical detail that ultrasound provides,“ Catherine Theodoropoulos, director of product management for VisualSonics, said. “So we're combining two very unique imaging modalities into one.“

She added that “it's all about providing tools that are going to allow us to visualize the environment and the behavior of tissues and organs,“ she said. “You can use [the technology] for example, if you want to study the tumor itself, or if you have a specific drug you're developing. You can see if that drug is going to affect kidney function; if it's going to affect the heart's function; or what affect the drug is going to have on other organs in the body.“

Applications for the Vevo LAZR system range from lymph node imaging, study of hemoglobin and oxygen saturation, and targeted imaging of tumor biomarkers. In addition to cancer biology, this cutting-edge imaging system will benefit other areas of research such as diabetes, neurosciences, as well as developmental and reproductive biology.

To date, the Vevo Lazr Photoacoustics Imaging system is only being used in animal models but plans could change for that.

Plans call for the company to eventually migrate the technology toward use in humans.

“But for now we're focused on making this technology successful for the preclinical space,“ Anil Amlani, VisualSonics' president/CEO said. “I believe that as soon as researchers begin to use our technology for clinical research, they will find all kinds of clinical implications – and you know what . . . they're going to push us to take [the Vevo Lazr Photoacoustics Imaging system] into the clinic.“

In a statement, he said “the Vevo LAZR photoacoustics system is a breakthrough in vivo imaging technology. Advancements featured in this product will enable oncology researchers to accelerate their research into understanding the inner workings of the cancerous cell and the host tissue in which it resides. The ability to conduct this microscopic level research in a living organism, non-invasively and in real-time, will help our customers to turn ground-breaking science into lifesaving care at an even greater speed.“

To date, the application is available worldwide and has been generating buzz among researchers. The firm found out how much when it attended AACR this year and received comments about the technology.

According to the company, the device, which can be a potential platform technology, was well-received. There were even reports of some researchers applying for grants to purchase the device.

“I think researchers have been waiting for a long time to actually have this imaging modality and to have a non invasive and quantifiable way to look at the expressions of celluar and molecular markers in vivo,“ Theodoropoulos said.

Sonosite's CEO commented on the technology in a statement saying that it had the potential to be a “gamechanger“ in the imaging technology space.

“The launch of the Vevo LAZR technology further demonstrates our commitment in providing game changing imaging technology to advance pre-clinical research,“ said Kevin Goodwin, SonoSite's president/CEO. “We are confident that the photoacoustics technology will provide never-before-seen insights into cancer research and will have a strong impact on the discovery of new therapeutics.“

Elsewhere in the product pipeline:

• Allpro Imaging (Melville, New York), a provider of computed radiography systems, has introduced the Healthcare 360° – the complete turnkey solution to going digital. Allpro's new PACSmart Imaging Software is now paired with the classic ScanX 12 and the portable ScanX Fit computed radiography systems. The packages offer a ScanX system and a desktop workstation or laptop computer. Packages also include imaging plates, plate protectors and cassettes, installation, customer support, and a 12-month swap warranty. The company said its Healthcare 360° CR packages streamline the process of switching to digital imaging. There is no longer any need to deal with recurring costs of film, chemistry, darkrooms or processor maintenance. Instead of traditional film these CR systems utilize durable, flexible phosphor storage plates (PSPS) which are coated with photostimulable material. Upon exposure the plate stores a latent image which is then scanned by the system.

• AngioDynamics (Latham, New York) reported the U.S. launch and initial shipments of the next generation DuraMax stepped-tip chronic dialysis catheter and the DuraMaxVP (VascPak) kit. The DuraMax catheter provides optimal ease of insertion and high performance blood flow rates. It features a proprietary guidewire lumen designed to significantly improve catheter placement by securely fixing the guidewire in the center of the leading edge of the catheter at the insertion site. The new DuraMaxVP (VascPak) product offers a streamlined component kit designed to appeal to vascular access centers and open this new segment for AngioDynamics. Up to 45% of all chronic dialysis catheter placements – more than 180,000 placements in 2011 – are performed in these outpatient centers. AngioDynamics, is a provider of minimally invasive devices used by professional healthcare providers for vascular access, surgery, treatment of peripheral vascular disease and oncology procedures.

CryoLife (Kennesaw, Georgia), an implantable biological device and cardiovascular tissue processing company, reported that it has filed an IDE with the FDA to begin clinical trials for the purpose of obtaining a PMA to distribute PerClot in the U.S. to control bleeding during surgical procedures or following traumatic injuries. PerClot is a unique, absorbable powder hemostat and is intended for use in surgical procedures when control of bleeding by pressure, ligature, and other conventional means is either ineffective or impractical. The therapeutic areas in which PerClot will be used consist of cardiac, general, urological, orthopedic, and neurosurgical procedures. PerClot has CE Mark designation and CryoLife began distributing PerClot in several international markets in 4Q10. CryoLife's proposed IDE study would include a total of about 330 patients in a randomized, prospective, multicenter trial. The primary objective would be to evaluate the hemostatic effectiveness of PerClot vs. control hemostatic devices (Gelfoam and Surgicel) at 5 minutes. Efficacy would be assessed by comparing intraoperative time to hemostasis (primary endpoint). The secondary objectives would be to evaluate the proportion of subjects with hemostasis at 1, 3, 7, and 10 minutes after trial treatment. Safety endpoints would include but are not limited to the incidence of reoperation due to bleeding, total hospitalization time, and the incidence of procedure complications and/or adverse events through final patient follow-up.

• AngioScore (Fremont, California) reported the launch of new, longer AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD). The devices have received FDA clearance for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These new PTA catheters are not labeled for use in the coronary or neuro-vasculature. The new AngioSculpt devices use longer (40 mm) balloons and scoring elements in diameters 2.0, 2.5, 3.0 and 3.5 mm. These new sizes are expected to be particularly useful in treating lesions typically encountered in the treatment of complex PAD below the knee.

• Boston Scientific (Natick, Massachusetts) reported the start of patient enrollment in the SuperNOVA clinical trial, an international, prospective, single-arm, non-randomized trial evaluating the safety and effectiveness of the Innova self-expanding bare-metal stent system in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA). The stent system is designed to treat peripheral vascular lesions in arteries above the knee, specifically the SFA and PPA. It consists of a nitinol, self-expanding bare-metal stent loaded on an advanced low-profile delivery system. The architecture features a closed cell design at each end of the stent for improved radial force and fracture resistance, and an open cell design along the stent body that doesn't compromise flexibility. Stent deliverability is enhanced with a tri-axial catheter shaft designed to provide added support and placement accuracy as well as dual deployment options and radiopaque markers to enhance ease of use. The Innova stent is 6F compatible and ranges from 5 mm to 8 mm in diameter and 20 mm to 200 mm in length.

• CardioNexus (Houston), an affiliated company of Panasonic Healthcare, will introduce Panasonic CardioHealth Station at the 2011 Annual Scientific Sessions of the American College of Cardiology. The product, which has just received clearance from the FDA, is an automated and portable cardiovascular imaging device which aims to complement traditional blood pressure and cholesterol measurement in physicians' offices and to help detect the hidden risk of heart attack and stroke. The device, which relies on Panasonic's ultrasound technology, measures the thickness of the arterial wall through the skin quickly and reproducibly. It is considered a major advancement in the automation of medical technologies which enable physicians, their assistants, and nurse practitioners who are not specialized in ultrasound imaging to use the device and detect high risk patients. The CardioHealth station includes a handheld ultrasound probe to scan the carotid arteries on both sides of the neck and to detect hidden plaque build up and increased thickness in the artery wall.

• Covidien (Mansfield, Massachusetts), reported interim results of its multicenter, international, prospective SILS Port laparoscopic cholecystectomy (removal of the gall bladder) post-market clinical study. The interim topline results of the study were reported during a podium presentation at SAGES 2011. The prospective, randomized, controlled trial was designed to assess the feasibility and safety of performing gall bladder surgery via a single incision through the belly button with the aid of Covidien's SILS Port. The study protocol allows participating surgeons to objectively document the scientific merit and the perceived advantages using the SILS Port through a single incision over a traditional laparoscopic technique (four incisions). The participating surgeons will monitor patients in the study for a year after the procedure to track their pain, quality of life and the cosmetic appearance of their abdomens. All 200 patients have now been enrolled in the study; this data analysis includes preliminary results of 189 patients. The 111 patients who underwent gall bladder surgery with the single incision approach reported significantly better cosmetic outcomes up to three months after their procedures, compared to the group whose surgeons used four laparoscopic ports. The pain scores between the two groups were within one point of each other on a 10 point visual analog scale rendering pain as clinically similar between the two groups.

• Hospira (Lake Forest, Illinois), a provider of clinical information and medication delivery technologies, reported the launch of its enhanced TheraDoc clinical surveillance system, used by hospitals to help improve patient safety and prevent adverse events such as healthcare-associated infections (HAIs). The enhanced TheraDoc system includes new features and functionalities designed to improve user satisfaction, reporting capabilities and work efficiency. The TheraDoc platform enhancements are designed to help hospitals meet and improve upon evolving quality metrics and national patient safety goals. The new platform also helps clinicians more easily identify antimicrobial resistant pathogens and drug-bug mismatches. Improvements to the TheraDoc Infection Control Assistant module facilitate seamless electronic reporting of HAIs to the National Healthcare Safety Network and provide a new infection control dashboard for enhanced reporting, data comparison and benchmarking. Clinicians and healthcare institutions can now use TheraDoc to automatically track and generate electronic reports regarding urinary tract infections, central line insertion practices, laboratory-identified multi-drug resistant organisms and C. difficile-associated disease events. This additional functionality will help to decrease manual sorting of laboratory results and streamline public health reporting.

• ICU Medical (San Clemente, California) has introduced the MicroCLAVE Clear Neutral Displacement Needlefree Connector. MicroCLAVE Clear allows clinicians to visualize the fluid path, verifying effective flushing of the patient catheter after use with blood and medications that could leave residual or fluid precipitates after aspiration or infusion. The connector's clinically proven MicroCLAVE design effectively clears blood and blood residual with flush volumes as low as 2.0 mL, while the connector's clear housing allows for visualization of the internal fluid path upon flushing the connector. Part of a full line of MicroCLAVE connectors that includes the original MicroCLAVE and the antimicrobial MicroCLAVE, MicroCLAVE Clear shares the design features that have been clinically proven to provide a safe and effective microbial barrier. The neutral displacement straight fluid path design, split-septum, and minimal deadspace of the MicroCLAVE work together to help minimize blood reflux into the tip of the catheter upon connection or disconnection of the luer.

• IRIS International (Chatsworth, California), a manufacturer of automated in vitro diagnostics systems and consumables for use in hospitals and commercial laboratories, and a provider of high-value personalized diagnostics testing services through its CLIA-certified molecular diagnostics laboratory, reported that, following recent 510(k) market clearance, it has commenced the U.S. commercial activities with the shipment in March of its iChem velocity automated urine chemistry analyzers in combination with its iRICELL Urinalysis Workstations to three U.S. hospitals. While it was pursuing U.S. regulatory clearance, IRIS received CE mark certification and launched the iChemVelocity to the international marketplace in September 2008, and since that time has sold more than 300 instruments in more than 30 countries. The iChemVelocity system is designed to deliver improved productivity and clinical use in the medium-to-high volume hospital and clinical reference labs.

• Keystone Dental (Burlington, Massachusetts) reported the launch of DynaMatrix Plus, a soft tissue regeneration product specifically designed to serve as an alternative to patient's own tissue for root coverage and tissue bulking procedures. DynaMatrix Plus is a bioactive soft tissue regeneration product that has been specifically designed for soft tissue augmentation procedures. The design of DynaMatrix Plus enables generation of tissue of increased depth for root coverage and tissue bulking procedures. Keystone says the DynaMatrix technology is unique because it contains active signaling proteins, allowing the material to work with the patient's own tissue and jumpstart the natural healing process.

• Medtronic (Minneapolis) reported FDA approval of InterStim therapy for bowel control. InterStim Therapy, previously available to treat the symptoms of overactive bladder and non-obstructive urinary retention, is now also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. InterStim therapy for bowel control is a new, minimally invasive option proven to improve or restore bowel control in more than 80% of patients who received the therapy in a multi-center clinical trial. The implantable InterStim system uses mild electrical stimulation of the sacral nerves to influence the behavior of the pelvic floor muscles and bowel. As a result, the therapy significantly reduced fecal incontinent episodes for a high percentage of clinical trial patients.

• NeuroVasx (Maple Grove, Minnesota) reported that the FDA has approved the cPAX aneurysm treatment system as a Humanitarian Use Device (HDE) for the treatment of large, giant and wide-neck cerebral aneurysms, which are typically the most difficult to treat. The HDE allows for the treatment of up to 4,000 patients per year in the U.S. A cerebral aneurysm is an abnormal bulge or sac in the wall of an artery in the brain which can be caused by a number of factors including congenital defects, high blood pressure, atherosclerosis, cancer, drug use or head trauma. If a cerebral aneurysm ruptures, it can lead to a hemorrhagic stroke, or bleeding on the brain. cPAX is a polymeric strand delivered into the aneurysm using a technique similar to currently available platinum coil technologies. cPAX, because of its soft polymeric material, is designed to achieve more complete filling of the aneurysm with the probable benefit of greater long term stability. A significant feature of cPAX in comparison to currently available technologies is that it offers the physician the ability to detach the device at any point versus a fixed detachment zone common in platinum coils. The polymeric material also allows for non-invasive CT and MRI scans with little or no artifact for more accurate patient follow-up assessment.

• PerkinElmer (Waltham, Massachusetts) has introduced a new oncology testing service which uses the OncoChip, a microarray technology to aid in faster, earlier and more accurate diagnoses of hematological malignancies. The OncoChip technology assists physicians and clinicians by quickly identifying chromosome abnormalities, including gains, losses and balanced translocations to aid physicians in providing patient diagnosis and prognosis. The results of the OncoChip microarray technology may allow for more targeted, rapid and accurate treatments of patients with hematological cancers, such as chronic lymphocytic leukemia, chronic myelogenous leukemia, acute myeloid leukemia, T-cell and B-cell acute lymphoblastic leukemia.

• PLC Systems (Franklin, Massachusetts) reported that final results from the REMEDIAL II investigator-sponsored clinical trial of its RenalGuard System were presented at ACC scientific sessions. The REMEDIAL II trial is a randomized multi-center clinical trial in Italy designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy using RenalGuard, compared to a control group, in reducing the incidence of Contrast Induced Nephropathy (CIN) in patients with baseline impairment in renal function undergoing cardiac catheterization procedures and percutaneous coronary interventions. RenalGuard is designed to reduce the potentially toxic effects that contrast media can have on the kidneys when it is administered to patients during certain medical imaging procedures. The RenalGuard System consists of a console and accompanying single-use sets. RenalGuard is intended to promote and maintain high urine outputs and minimize the risk to patients of over- or under-hydration during image-guided catheterization procedures where contrast media are routinely administered.

St. Jude Medical (St. Paul, Minnesota) has received FDA approval of two new irrigated ablation catheters – the Safire BLU Bi-directional Irrigated Ablation Catheter and the Therapy Cool Path bi-directional ablation catheter. These two new catheters have several key design features that offer physicians additional control, including bi-directional deflection, a new shaft with higher torque response, a lower fluid infusion rate when compared to other commercially available irrigated ablation systems, and a choice of handles. Because the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature, the Safire BLU and Therapy Cool Path ablation catheters were designed with an irrigated catheter tip. Irrigation can help to reduce some of the risk factors associated with the heat of the RF energy. The Safire BLU and Therapy Cool Path irrigated ablation catheters feature a bi-directional deflection capability that provides enhanced maneuverability, which allows physicians to reach challenging anatomic locations. The bi-directional steering turns up to 180 degrees in both directions to allow physicians to better position the tip of the catheter during ablation procedures.

• University Medical Professional (Irvine, California) has introduced the Ion-Infusion Eye Renewal system, which the company claims is the only product in the world to significantly reduce wrinkles without injections. This system bridges the gap between traditional anti-aging creams and in-office procedures. The Ion-Infusion Eye Renewal System's approach addresses wrinkle reduction by pairing targeted topical treatments with an advanced ion-based technology to safely deliver wrinkle treatments into the surface layers of the skin. In 40 minutes, each treatment is designed to help firm, tighten and significantly reduce the appearance of fine lines and wrinkles.

• Ventus Medical (Belmont, California) reported positive results from a 19 center clinical trial using its FDA-cleared Provent device to treat obstructive sleep apnea. Provent therapy uses the patient's own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The primary endpoint of the study was the reduction in apnea-hypopnea index (AHI). In-laboratory polysomnography, a method of monitoring breathing disruptions during sleep, was performed at the start of the study and after three months of treatment. Results at the start of the study showed that AHI was reduced by 52.7% in the Provent therapy group compared to a 7.3% reduction in the sham group, representing a highly significant treatment effect.

• Vexim (Toulouse, France), a specialist in medical instruments designed for the minimally invasive, anatomical treatment of vertebral compression fractures, reported that it has been awarded FDA clearance for its new product Cohesion, a bone cement for injection into the vertebra following minimally invasive spinal fracture anatomical restoration with the company's SpineJack device or used in performing a conventional vertebroplasty.

• Vicor Technologies (Boca Raton, Florida) submitted its response to FDA inquiries concerning its 510(k) premarket notification for its PD2i nonlinear algorithm and software to be used in cardiovascular disease testing. The PD2i Analyzer is a non-invasive diagnostic using its patented, proprietary PD2i nonlinear algorithm. The PD2i Analyzer enables physicians to accurately risk stratify specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention. This submission is a response to inquiries received from the FDA during its routine review of the company's 510(k) premarket notification originally submitted in 2010.