Category Archives: Cryoablation

Galil Medical Launches SOLSTICE, Clinical Trial for Lung Cryoablation

Arden Hills, MN—DATE March 24, 2014 —Galil Medical, the global leader in interventional oncology cryotherapy treatments, announced the launch of its latest prospective clinical research study, SOLSTICE (Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation).

The SOLSTICE Clinical Study is the largest multi-center prospective trial focused on the clinical use and effectiveness of cryotherapy treatments for patients with primary cancer lesions that have metastasized to the lung. The study calls for two years of follow up, with a projected enrollment of approximately 125 patients. This study follows on Galil Medical’s successful ECLIPSE (Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients – Safety and Efficacy) clinical research study, which reported on 40 subjects in 2013 and is continuing in its patient follow-up stage.

Matthew Callstrom, M.D., Ph.D., Mayo Clinic, Rochester, MN and Thierry de Baere, M.D., Institut Gustave Roussy, Paris France will serve as the trial lead investigators.

Dr. de Baere commented, “My colleagues and I are pleased that we are a part of the SOLSTICE study. Following our experience with the ECLIPSE trial we look forward to better understanding the role cryoablation can play in our clinical practice and the management of lung metastasis.”

“We are thrilled that many of the leading oncology institutions across the U.S. and Europe are participating in this milestone clinical trial focused on treating a patient population that we believe will benefit from cryoablation solutions” stated Martin J. Emerson, President and CEO of Galil Medical. “SOLSTICE, as well as our other clinical studies and active R&D pipeline, will further cement that Galil is the only company in the world solely committed to advancing cryotherapy over a broad range of applications and indications,” Emerson continued.

For a listing of all the sites participating in the SOLSTICE study, along with further information regarding the SOLSTICE and ECLIPSE studies, as well as other clinical studies please visit www.clinicaltrials.gov.

Galil Medical continues to invest heavily in both new product innovations and clinical research. Currently, the company has eight active clinical research studies underway in the kidney, lung, bone, pain and prostate arenas in the U.S., Canada and Europe.

About Galil Medical:
Galil Medical is a global leader in delivering innovative cryotherapy solutions. The company is addressing patient conditions across multiple physician specialties; treatment areas include conditions affecting bone, kidney, liver, lung and prostate, as well as targeted pain and nerve applications. Company offices are located in Arden Hills, Minnesota and Yokneam, Israel. Shareholders include Thomas, McNerney & Partners, The Vertical Group, and Investor Growth Capital.

Contact information:

Martin J. Emerson
President and CEO
Tel: +1 651 287 5050
Email: marty.emerson@galilmedical.com

Maria Plentl, MSN
Senior Director, Global Clinical Research
Tel: +1 651 287 5057
Email: maria.plentl@galilmedical.com

Icy therapy spot treats cancer in the lung

From the Society of Interventional Radiology:

Cryoablation: lnterventional radiologists present results of research on a new minimally invasive treatment option for advanced cancers that have spread to lung tissue.

Frozen balls of ice can safely kill cancerous tumors that have spread to the lungs, according to the first prospective multicenter trial of cryoablation. The results are being presented at the Society oflnterventional Radiology’s 38th Annual Scientific Meeting in New Orleans.

“Cryoablation has potential as a treatment for cancer that has spread to the lungs from other parts of the body and could prolong the lives of patients who are running out of options,” said David A. Woodrum, M.D., Ph.D., an author of the study and interventional radiologist at the Mayo Clinic in Rochester, Minn. “We may not be able to cure the cancer, but with cryoablation we can at least slow it down significantly and allow patients to enjoy greater quality of life longer,” he added. Metastatic lung disease is difficult to treat and often signals a poor prognosis for patients.

In the initial results of the study, called the ECLIPSE trial (Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients-Safety and Efficacy), 22 subjects with a total of 36 tumors were treated with 27 cryoablation sessions. Cryoablation was 100 percent effective in killing those tumors at three-month follow-up. Follow-up at six months on 5 of the 22 patients (23 percent) showed the treated tumors to still be dead. Cryoablation is performed by an interventional radiologist using a small needle-like probe guided through a nick in the skin to cancerous tumors inside the lung under medical imaging guidance. These tumors have spread-or metastasized-to the lung from primary cancers in other areas of the body. Once in position, the tip of the instrument is cooled with gas to as low as minus 100 degrees Celsius. The resulting halo of ice crystals can destroy cancer by interrupting its cellular function, protecting nearby healthy, delicate lung tissue. Lung cryoablation has been promising in part due to the low periprocedural morbidity.

“Most of these patients can go home the day after their cryoablation treatment and resume their normal activities,” Woodrum said, noting that researchers plan to continue to follow patients for up to five years. While cryoablation is being developed for the treatment of metastatic lung cancer, the future looks brighter for individuals who once had nowhere else to turn, said Woodrum, who was assisted in research by Frank Nichols, M.D. and Matthew R. Callstrom, M.D.

Highlights

  • Minimally invasive cryoablation freezes and kills cancerous tumors that have spread to the lung, suggests first results of the ECLIPSE trial.
  • Cryoablation was 100 percent effective after three months, researchers found.
  • While not a cure, ccyoablation appears to extend patient survival.
  • Interventional radiologists are doctors who specialize in minimally invasive targeted treatments. They use X-rays, MRI or other imaging to guide a catheter inside the body, usually in an artery, to treat at the source of disease.

More information about the Society oflnterventional Radiology, interventional radiologists and minimally invasive treatments can be found online at www.SIRweb.org.

Abstract 33: “Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients-Safety and Efficacy (ECUPSE), ” T. de Baere, G. Farouil, lnstitut de Cancerologie Gustave Roussy, VillejuifCedex, France; D.A. Woodrum, Mayo Clinic, Rochester, Minn.; F. Abtin, University of California-Los Angeles, Los Angeles, Calif.; P. Littrup, Karmanos Cancer Institute, Detroit, Mich., SIR 38th Annual Scientific Meeting, April 13-18, 2013. This abstract can be found at www.SIRmeeting.org.

Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments. They offer the most in-depth knowledge of the least invasive treatments available coupled with diagnostic and clinical experience across all specialties. They use X-ray, MRI and other imaging to advance a catheter in the body, such as in an artery, to treat at the source of the disease internally. As the inventors of angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease, interventional radiologists pioneered minimally invasive modem medicine. Today, interventional oncology is a growing specialty- area of interventional radiology. Interventional radiologists can deliver treatments for cancer directly to the tumor without significant side effects or damage to nearby normal tissue.

Many conditions that once required surgery can be treated less invasively by interventional radiologists. Interventional radiology treatments offer less risk, less pain and less recovery time compared to open surgery. This year, SIR celebrates 40 years of  innovation and advances in interventional radiology. Visit www.SIRweb.org.

Galil Medical Announces Introduction of IceRod® CX Cryoablation Needle

Galil Medical, a global leader in minimally invasive  cryotherapy cancer treatments, announced today that they received FDA 510(k) clearance to market their new IceRod® CX Cryoablation Needle.

The new IceRod CX Cryoablation Needle is an innovative technology that combines two different thermal energies in a single ultra-thin cryoablation needle. Cryotherapy, delivered at extremely low temperatures, provides a minimally invasive option to treat tumors for appropriate patients. Cautery, delivered at a high temperature, provides the physician with track ablation options at the end of the procedure.

For customers choosing to use active thaw, the IceRod CX Needle incorporates the company’s exclusive i-Thaw® feature, a proprietary technology that eliminates helium supply costs and reduces cryotherapy procedure set up time for hospitals.

The IceRod CX Needle is designed for use exclusively with Galil Medical’s recently introduced Visual-ICE® Cryoablation System, the latest cryoablation technology and a platform for the company’s future generations of needle products.

“We are excited to introduce this innovative product, our fourth product introduction in the past 14 months. The combination of our ultra-thin needles, increased clinician control using our new Visual-ICE System, and now the additional patient benefits with our IceRod CX Needle, creates significant benefits for our customers,” said Martin J. Emerson, president and chief executive officer of Galil Medical.

The company continues to invest heavily in both new product innovations and clinical research. Galil Medical launched the IceRod® PLUS Cryoablation Needle and the IceEDGE® 2.4 Cryoablation Needle in 2011. The company is developing additional innovative needles and plans to launch these new products within the next several months. Currently, the company has 10 active clinical research studies underway in the prostate, kidney, lung, bone and pain arenas in the U.S., Canada and Europe.

“Galil Medical is the only company solely committed to advancing cryotherapy over a broad range of applications,” Emerson continued. “Introduction of this unique combination of ice and cautery in the IceRod CX Needle builds on the success of multiple recent product launches and affirms our position as the world’s preeminent cryotherapy company. We strive to provide our clinicians with a broad range of product choices, allowing them to select and tailor each clinical solution to match a specific patient need.”

Galil Medical Announces Introduction of Visual-ICE® Cryoablation System

Galil Medical, a global leader in minimally invasive cryotherapy cancer treatments, announced today that they received FDA 510(k) clearance to market their new Visual-ICE® Cryoablation System. The company will showcase their new system at the Society of Interventional Radiology meeting this week in San Francisco, as well as at the upcoming European Congress of Interventional Oncology meeting, the American Urological Association meeting and the 5th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer.

The new system capabilities promote more precision and flexibility for the user, allowing for increased control over the shape and size of individual iceballs. Further, the system simplifies and shortens cryoablation procedures, including the operation and monitoring of the procedure from a large, single touch-screen.

The Visual-ICE Cryoablation System is the first oncology focused cryoablation system introduced in over 6 years, engineered with multiple physician specialties in mind, and will be the platform technology for the company’s next generation needle products.

Faster overall procedure times, the ability to concurrently treat larger and/or multiple lesions are some of the additional features of the company’s new Visual-ICE system. The new system will also leverage i-Thaw®, the company’s proprietary argon-only needle technology, resulting in lower operating costs for hospitals.

The company continues to invest heavily in new product innovations and clinical research. The Visual-ICE Cryoablation System further enhances Galil Medical’s position as the preeminent cryotherapy company in the world. Galil Medical’s collaborative approach with its customer base was evident in the development process for Visual-ICE, as countless hours were invested in feedback sessions with physicians, nurses and technicians to better understand their specific needs.

“The Visual-ICE System represents the latest example of our commitment to advancing cryotherapy,” commented Martin J. Emerson, President and CEO of Galil Medical. “Our goal with the Visual-ICE System is to enhance the user experience. Through state of the art software and technology, this new system will provide the user with more intra-procedural precision and control. We look forward to meeting the needs of our physician customers for many years to come.”

Galil Medical launched the IceRod® Plus Cryoablation Needle and the IceEDGE® Cryoablation Needle in 2011. The company is developing many more new needles and plans to launch four new needles within the next 18 months.

“Galil Medical is the only company solely committed to advancing cryotherapy over a broad range of applications,” Emerson continued, “We believe that the introduction of the Visual-ICE System will further solidify our position as the world’s preeminent cryotherapy company. Our goal is to provide our clinicians with a broad range of product choices, supported by robust clinical data, allowing them the flexibility to treat a wider range of patients.”