A Medical Device Daily

Endocare (Irvine California), focused on the development of minimally invasive technologies used for tissue and tumor ablation, reported that the National Cancer Institute (NCI) of the National Institutes of Health is supporting a multi-center study comparing the pain-reducing effects of cryoablation and radiation therapy for patients experiencing focal pain from cancer that has metastasized to the bones.

The study, called Cryoablation And Radiation Effectiveness (CARE) for Bone Pain and led by interventional radiologist Matthew Callstrom, MD, PhD, of Mayo Clinic (Rochester, New York) will evaluate the efficacy of percutaneous cryoablation compared to external beam radiation therapy (RT) as measured by pain relief, quality of life, analgesic use and complication rates. Callstrom is leading another multi-center study on cryoablation of painful metastatic disease.

The trial is open to patients through the NCI oncology group network and conducted by the North Central Cancer Treatment Group. A total of 128 patients is expected to take part in the study.

Percutaneous cryoablation is a minimally invasive procedure in which tumors are targeted with ultrasound, CT or MRI guidance and treated by freezing to destroy or ablate the tumor. The Endocare Cryocare System will be used to treat all patients in the cryoablation arm of the study. Endocare will also contribute to the funding of the study.

Craig Davenport, president/CEO and chairman of Endocare, said that the bone is the most common site of metastases and that many patients do not get adequate pain relief from conventional treatments, suih as chemotherapy, radiation or other drug therapies.

“This is a very important study for Endocare but also for the thousands of patients who are suffering from the spread of cancer to the bone and who have very few viable options to relieve the pain it causes while retaining an active lifestyle,” Davenport said.

Davenport noted that Endocare has FDA clearance to ablate tumors and tissue throughout the body, including this percutaneous cryoablation for palliation of painful metastatic lesions. He said it is hoped that the study will demonstrate that cryoablation is effective in bone cancer and this could be important to gain positive reimbursement decisions from both government and private payers.

In other agreements:

• Global Care Quest (GCQ; Aliso Viejo, California) reported that KARL STORZ Endoscopy-America (Culver City, California), a developer of minimally invasive endoscopic technologies and operating room integration, has expanded their marketing relationship to offer GCQ’s ICIS OR LIVE solution with KARL STORZ OR1 operating room integration technologies. The result of this collaboration will be to give operating room teams a customizable, comprehensive view of available video sources and image data for each surgical patient.

As still and video image sources available to the OR have expanded, surgeons have required increased access to multiple monitors and displays. The addition of GCQ’s ICIS OR LIVE technology delivered through the KARL STORZ OR1 enables intuitive and effective access to the expanded range of data and information provided by GCQ. For the first time, clinicians are given the ability to configure the display of those sources — to rearrange, resize and adjust the video and still images — to suit individual preferences and to optimize patient care in the OR, the companies said.

GCQ ICIS OR LIVE integrates a range of data from disparate information systems throughout the hospital, and through the KARL STORZ OR1 touchscreen user interface, this information can be displayed in optimal locations throughout the operating room to enhance a surgeon’s clinical effectiveness. Surgeons can also gain remote access to this data, and with the OR1^® system, all available video sources in the OR can be viewed remotely, including endoscopic and microscopic images, and surgical in-light and room camera views.

ICIS OR LIVE also provides the ability to configure PACS images. The surgeon can zoom, pan, tilt or rotate image displays, as well as change window/level contrast, do multi-slice scrolling, or switch from static to cine mode to view a patient’s video data.

• HepaLife Technologies (Boston) reported that the company has entered into a new Cooperative Research and Development Agreement with the USDA Agricultural Research Service (USDA, ARS) for further optimization of HepaLife’s PICM-19 liver stem cell line for application in the first-of-its-kind bioartificial liver device.

Incorporating the PICM-19 cell line, HepaLife is developing the first-of-its-kind bioartificial liver. HepaLife’s bioartificial liver, currently under development, is designed to operate outside the patient’s body. The bioartificial liver is envisioned to mimic important functions of the human liver by circulating the patient’s blood inside the device, where it is exposed to HepaLife’s PICM-19 liver stem cells, thus processing the patient’s blood-plasma by removing toxins, enhancing metabolic function, and ultimately, imitating the liver’s natural function.

Intended for the treatment of liver failure, the HepaLife Bioartificial Liver device consists of three basic components: a plasma filter, separating the patient’s blood into blood plasma and blood cells; the bioreactor, a unit filled with PICM-19 cells which biologically mimic the liver’s function; and the HepaDrive, a perfusion system for pumping the patient’s plasma through the bioreactor while controlling gas supply and temperature for best possible performance of the cells.

HepaLife is a developer of cell-based medical technologies addressing prevalent human health concerns.