BB&T Senior Staff Writer

There has to be a better way.

That sentiment is what inspired the development of a new breast tissue expansion device for mastectomy patients undergoing breast reconstruction. The device, called AeroForm, was developed by AirXpanders (Palo Alto, California), which recently received an investigational device exemption from FDA to move forward with a clinical trial evaluating the technology.

The prospective, randomized, controlled, open-label pivotal study, XPAND (AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction), will be conducted at multiple centers across the U.S. AirXpanders said the results will be used as the basis for its AeroForm 510(k) filing with the FDA.

Scott Dodson, president/CEO of AirXpanders, said that the current method for undergoing breast reconstruction following a mastectomy is a procedure during which the surgeon creates a space for a permanent implant. To do this, the surgeon makes a small incision into the woman's pectoral muscle and inserts a silicone bag. Then, during weekly office visits, the surgeon inserts a needle through the skin into the tissue expander's port to inject saline into the temporary implant. These weekly injections continue for upwards of four months, Dodson said.

So Daniel Jacobs, MD, a practicing plastic surgeon and one of the co-founders of AirXpanders, decided there had to be a better way.

What AirXpanders ended up coming up with was a breast tissue expansion device that would address the limitations of traditional saline expanders. The AeroForm tissue expander consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. Dodson said the system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. After a standard procedure to implant the expander, the patient is able to inflate the expander herself at home using the remote control, eliminating the need for weekly doctor visits and needle-based saline injections.

The patient can inflate the expander up to three times a day with a three-hour lock-out between doses. “We thought if we could expand the patient on a gradual daily basis we could get her there quicker,“ Dodson said.

The way the remote control part of the system works is that the patient waves it over the implant area to allow it to communicate with the implant.

“It's like using a stud finder on the wall to find out where a stud is,“ Dodson said. “This dose controller communicates when it is over the implant . . . once you're in the sweet spot you simply press the button and immediately a 10 cc dose is delivered.“

He said the company recently completed its feasibility trial in Australia which showed that the implant was able to reach full expansion in about two weeks using the new device.

“This is a significant event in the fact that women want to get on to the recovery phase after they've gone through this horrible ordeal with cancer . . . we validated that we can help get them there quicker,“ Dodson said.

AirXpanders noted that the randomized, controlled clinical trial is designed to directly compare the outcomes of tissue expansion using the traditional saline expansion method to the investigational AeroForm, remote-controlled, needle-free tissue expander. Enrollment will continue until a total of 92 AeroForm devices have been implanted and 46 saline expanders have been implanted. Dodson said the company expects the trial to take six to eight months to complete.

Participating sites include hospitals in Atlanta, Boston, New York, St. Louis, San Diego and other cities across the U.S., the company noted.

Elsewhere in the products pipeline:

• AB Sciex (Framingham, Massachusetts) reported the extension of its Eksigent line of column chips for the cHiPLC-nanoflex system. Five new chips were introduced at the HUPO (Human Proteome Organization) conference, expanding the flexibility and application of the system for high-performance proteomics analysis, including biomarker discovery, validation and verification. The company says the extended offering adds higher flow micro cHiPLC columns for peptide separation at increased throughput levels, as well as new phases for the analysis of intact proteins, phosphopeptides and glycans.

• AngioScore (Fremont, California) reported the launch of its new 100 mm AngioSculpt PTA Scoring Balloon catheters for the treatment of peripheral artery disease (PAD). These new AngioSculpt catheters have received FDA clearance to market for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal 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 catheters use longer 100 mm Scoring Balloons in diameters of 4.0, 5.0, and 6.0 mm. These catheters are expected to be particularly useful in treating lesions typically encountered in the treatment of complex PAD above the knee. The AngioSculpt Scoring Balloon's nitinol scoring elements provide circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding “geographic miss“ through their unique anti-slippage properties, the company said.

• Baxter International (Deerfield, Illinois) said the FDA has expanded the indication of ARTISS [Fibrin Sealant (Human)] to include adhering tissue flaps during facial rhytidectomy surgery (face-lift). ARTISS is a premixed, ready-to-use fibrin sealant specifically indicated for tissue adherence in facial rhytidectomy (face-lift) and burn surgeries. It was first approved by the FDA in 2008 to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations one year of age or older.

• Caliper Life Sciences (Hopkinton, Massachusetts) reported the availability of the IVIS Spectrum CT, a preclinical imaging system that integrates, into a single instrument system, advanced optical imaging and low-dose microCT (micro computed tomography). Spectrum CT enables simultaneous molecular and anatomical longitudinal studies, providing researchers with vital, unparalleled insights into complex biological systems in small animal models used to develop new, clinically translatable discoveries. A broad array of applications exist for the new instrument, with musculoskeletal, vascular, oncology, phenotyping, cardiovascular and respiratory disease among those areas particularly enabled by the integration of optical and microCT imaging.

• Carestream Molecular Imaging (Woodbridge, Connecticut) reported the introduction of the In-Vivo Xtreme, the newest addition to its family of multimodal imaging products dedicated to preclinical research. Xtreme is powered by an innovative system architecture that provides the ultimate combination of sensitivity, speed and flexibility to meet the most demanding challenges and broadest range of applications for molecular imaging. One of the most compelling features of this new system architecture is the ability to precisely match camera choice with research needs, performance criteria and budget. Xtreme comes in two camera configurations. The front-illuminated 16MP camera is ideally suited for applications that demand high resolution, while the back-illuminated 4MP camera excels at very low light imaging experiments.

• Concentric Medical (Mountain View, California) reported the completion of enrollment of the TREVO study. The TREVO study is the first evaluation of Stentriever technology in a European, multicenter, prospective clinical trial. The TREVO study was designed to assess the ability of the Trevo system to remove the blood clots that cause strokes and to restore blood flow to the brain. The TREVO study used the latest generation of the Trevo retrieval system and the preliminary results are very promising. The interim revascularization rate in the first 36 patients was 96%. Thirty patients had 90-day follow up and 63% of these had a good outcome. A “good outcome“ was defined as being functionally independent at 90 days. The Trevo System is a thrombus retrieval system. The main component of the Trevo system is the Trevo retriever which introduces Stentriever technology, creating a new generation of retrieval devices to remove clots in acute stroke patients. Concentric Medical makes devices for ischemic stroke intervention.

• The Centers for Disease Control and Prevention (Atlanta) reported a new in-vitro diagnostic kit to diagnose human infections with seasonal influenza viruses and novel influenza A viruses with pandemic potential. The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel utilizes a three-module design. The modules incorporate and streamline previous versions of CDC's two separate FDA-cleared diagnostic test kits. The first module is used to identify and distinguish between infection with influenza A and B viruses. The second module can further classify influenza A viruses by subtype, such as H1N1, H3N2 or 2009 H1N1. And the last module specifically detects highly pathogenic avian influenza A (H5N1) virus infection in human respiratory tract specimens, in support of ongoing global preparedness efforts against a possible H5N1 bird flu pandemic.

• Delcath Systems (New York) reported top-line results from the metastatic colorectal (adenocarcinoma) cohort of the phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer. The company also confirmed plans to initiate a new Phase II single-arm study in the second half of 2012. The new study is intended to evaluate the efficacy of Delcath's chemosaturation system and its next-generation high efficiency filter in patients with colorectal cancer that is metastatic to the liver and is refractory to first line systemic chemotherapy. Delcath is a development stage specialty pharmaceutical and device company focused on oncology.

• DSM (Berkeley, California) reported a collaboration with vascular catheter developer and manufacturer PendraCare resulting in the launch of the Primum guiding catheters. PendraCare uses ComfortCoat hydrophilic coating, a DSM technology, in its line of Primum guiding catheters. The hydrophilic coating aids in smooth catheter introduction and positioning by lowering friction in tortuous and calcified anatomy and reducing the risk of vessel wall trauma, while significantly extending Primum guiding catheter's effectiveness over prolonged procedure times. The no slip-stick effect results in more accurate positioning in ostial lesions and reduced catheter friction results in real 1:1 torque control of the tip. The properties and characteristics that DSM's ComfortCoat coating provide include excellent lubricity, superior durability and adhesion as well as proven biocompatibility thereby making it an excellent material choice for catheters and guidewires in vascular, neurological, urinary and other applications.

• Echo Therapeutics (Philadelphia), maker of the Symphony tCGM system as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude SkinPrep system for transdermal drug delivery, said it is initiating a clinical study of its Symphony tCGM system. Echo's clinical study will enroll healthy volunteer subjects and will compare data obtained from its Symphony tCGM system with both the YSI 2300 STAT Plus Glucose Analyzer and a commercially available professional-use glucometer. The study will collect more than 900 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours. The study data will be blinded to study subjects and study personnel. A comparison of the data relative to the blood glucose values will determine the accuracy of Symphony.

• EnteroMedics (St. Paul, Minnesota) reported data from the company's VBLOC-DM2 ENABLE (DM2) trial evaluating the company's second-generation Maestro RC System in the treatment of obesity, diabetes and hypertension, was presented at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) in Hamburg. DM2 trial results presented at IFSO reflect statistically significant, sustained improvement in glycemic control and blood pressure, as well as clinically meaningful weight loss in obese, diabetic patients using the Maestro RC System. The Maestro RC System delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week. EnteroMedics developed VBLOC vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices.

• Iridex (Mountain View, California) reported the introduction of its new XP Module – a high-power factory-installed option for the Iridex IQ 532 green laser system. The IQ 532 XP is a multifunctional device that can be utilized by both ear, nose and throat (ENT) surgeons and ophthalmologists – expanding overall use and making a laser investment more attractive. The optional XP module doubles the power of the standard Iridex IQ 532, facilitating the rapid and efficient treatment of tissue while limiting unwanted thermal effects and provides ENT surgeons with a portable KTP 532 nm laser system that is optimized for their clinical needs. Our IQ 532 products are small, portable, depot serviced, and solid state semiconductor-based laser systems. Some notable features include a modern touch screen user interface, wireless foot switch control, and voice confirmation.

• Lifetime Products (Clearfield, Utah) said it is expanding its product depth and adding a new Health and Wellness product category. Initially, the new Lifetime Health and Wellness category will feature products like the award-winning Lifetime Tru-Motion Walking Cane already on the market, and a new full line of home safety accessories including bath and towel safety grab bars.

• Merit Medical Systems (South Jordan, Utah) has received regulatory approvals for multiple products. Merit recently received regulatory approval in China for its Laureate guide wire, Concierge guiding catheter, and Impress catheter. Merit also recently received FDA clearance for its EndoMaxx esophageal stent and its flow control device. The company also received approval for its Zeonex syringe, which will extend the shelf life of its Embosphere product line. Additionally, Merit received its first regulatory approval in Singapore for its EN Snare foreign body removal device. Merit makes disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy.

• Philips Electronics (Amsterdam, the Netherlands) reported the introduction of ClearVue, what the company calls a family of ultrasound solutions featuring innovative technology, smart design and ease of use to make high quality imaging available to a wider range of clinicians. The system features Active Array technology, a solution that harnesses the power of larger ultrasound systems, enabling 2-D, color and Doppler image quality for increased diagnostic confidence.

• Rexam Healthcare (Buffalo Grove, Illinois) has received FDA approval for its passive safety device for staked prefilled syringes – Safe'n'Sound. The device is designed to protect workers in the health sector from needle injuries and contamination from blood borne pathogens. The passive Safe'n'Sound device provides protection against the risks of being pricked by a soiled needle through a protective sheath which activates automatically once the medicine has been administered, the company claims. Rexam Healthcare makes packaging for containers and closures, drug delivery devices, metering pumps and valves and medical components to improve patients' health.

• Starkey Laboratories (Minneapolis) has introduced a new receiver-in-canal (RIC) style with a size 13 battery to the Wi Series hearing aid line. Wi Series is a wireless hearing aid solution engineered to deliver a better listening experience. It contains a noise reduction and speech preservation system and eliminates buzzing and whistling. Additionally, Wi Series has the ability to stream stereo sound directly from a TV, radio or computer to the hearing aids – meaning that one person can listen at a comfortable level directly through his or her hearing aids like wearing head phones, while those around them can listen at the volume that is most comfortable for them. All of this is done without the need for additional hardware or pairing. Wi Series is available in two styles of RIC hearing aids featuring size 13 and 312 batteries and ranging from 40-gain to the 70-gain Absolute Power.

• St. Jude Medical (St. Paul, Minnesota) said the first patient in a clinical study examining the safety and effectiveness of an ST segment monitoring feature in an implantable cardioverter defibrillator (ICD) has been implanted with the investigational device in the U.S. The ST Monitoring to Detect ACS Events in ICD Patients (Analyze ST) study will evaluate effectiveness of the feature in the Fortify ST ICD by analyzing its accuracy in detecting acute coronary events, such as myocardial infarction, commonly known as a heart attack. The ST segment is a section of an electrocardiogram (ECG) that depicts electrical changes between heartbeats. Changes in ST segments have long been studied in clinical settings using external devices as indicators for an obstruction of blood flow and oxygen to the heart muscle (cardiac ischemia). However, due to several limitations, it has not been practical to study them on a continual basis.