This Year in Interventional Oncology
Read below for summaries of some of the most important news from 2016 about interventional oncology therapies and devices.
University of Miami Creates First Department of Interventional Radiology
The University of Miami has created a Department of Interventional Radiology, the first standalone interventional radiology department at a United States institution. The approval comes after years of unprecedented growth of this specialty, both in research and clinical applications, at the University of Miami Miller School of Medicine and UHealth – the University of Miami Health System. Govindarajan Narayanan, MD, who has led the Division of Interventional Radiology at the Miller School for the past 11 years, has been named chairman of the department. A professor of interventional radiology, Narayanan has been a pioneer in interventional radiology and has spearheaded the introduction of many of the specialized clinical applications in interventional radiology that are now offered to patients at Sylvester Comprehensive Cancer Center and UHealth. Narayanan has built a team of 16 faculty members and 8 researchers who provide service to patients at 4 hospitals and 2 satellite facilities. Among them is renowned interventional oncologist Riccardo Lencioni, MD, who joined Sylvester as director of interventional oncology research from the University of Pisa in Italy and was the coauthor of a vision statement in 2005 that is widely considered the birth of interventional oncology.
CE Mark Awarded to Simplicit90Y Dosimetry Software
BTG plc and Mirada Medical announced CE Mark certification for the Simplicit90Y dosimetry software, designed to optimize the planning of 90Y selective internal radiation therapy (SIRT) and facilitate personalized treatment for patients with liver cancer. CE Mark certification follows approval for Simplicit90Y in Canada. BTG, in collaboration with Mirada Medical, have developed Simplicit90Y to be a customized, easy-to-use dosimetry software developed for rapid 90Y selective internal radiation therapy workflow. Simplicit90Y provides digital processing, review and reporting of medical images with unique options for data display, quality control, image manipulation, and quantification analysis. Together, these features allow for more standardized and consistent dosimetry planning and post-treatment validation, and the ability to personalize treatment for each patient.
A Focus on SBRT at the ASTRO Meeting
Data from several studies of stereotactic body radiation therapy (SBRT) in various patient populations and tumor types were presented at the 58th Annual Meeting of the American Society for Radiation Oncology (ASTRO). A multicenter trial of SBRT in prostate cancer showed high progression-free survival and low toxicity. Another study found that survival rates for elderly patients who received SBRT for early stage non-small cell lung cancer rose from roughly 40% to 60% over the past decade, concurrent with the increasing adoption of SBRT. Also, researchers found in a separate study that stereotactic radiosurgery for cancer patients who receive the treatment for brain metastases decreases the likelihood of local recurrence but shows no positive difference in terms of overall survival or distant brain metastases rates, when compared to observation alone following surgical resection of brain metastases. Also, for patients who have cancer that has metastasized to the brain, stereotactic radiosurgery results in statistically comparable survival rates, reduced cognitive decline and better quality of life, compared to whole brain radiotherapy. Another study found that stereotactic radiosurgery for cancer patients who receive the treatment for brain metastases decreases the likelihood of local recurrence but shows no positive difference in terms of overall survival or distant brain metastases rates, when compared to observation alone following surgical resection of brain metastases.
Philips OncoSuite for Advanced Tumor Analysis and Therapy Launched in Europe
Philips’ interventional oncology solution OncoSuite was unveiled at the 2016 Cardiovascular and Interventional Radiological Society of Europe annual meeting (CIRSE 2016) in Barcelona. OncoSuite was developed to enable physicians to provide analysis and minimally invasive, targeted treatment of tumor lesions reducing the impact to healthy tissue. It offers clinicians a view of the treatment targets for informed decision making, while performing the procedure, according to the company. OncoSuite is Philips’ integrated solution to enhance tumor embolization and ablation procedures with Philips’ interventional X-ray systems. It is the only platform in the industry that supports both procedures, enabling physicians to target multiple tumor lesions simultaneously. OncoSuite comprises Philips’ innovative product offerings for enhanced imaging (XperCT Dual), live 3D image guidance for tumor embolization (EmboGuide) and live 3D image guidance for tumor ablation (XperGuide). It allows targeted treatment of an entire tumor and its feeder vessels, sparing surrounding tissue or organs. The innovative Open Trajectory function within XperCT Dual enables better centering of the liver with significantly improved visualization during the procedure of peripheral hepatic tumors in a single sweep. This feature provides a more targeted field of view making it possible to effectively scan larger patients. Previously, with the traditional geometric movement of the C-arm of the interventional X-ray system, part of the liver image was truncated and larger patients required multiple scans to visualize tumors in the periphery of the liver.
“While OncoSuite can be used for a number of different cancers including bone, kidney and lung, the solution and its specific tools have been optimized for the treatment of patients with liver cancer,” said Jeff Geschwind, MD, Chairman and Chief of the Department of Radiology and Biomedical Imaging at the Yale School of Medicine, in a press release. “What matters most in these cases is the ability to visualize the liver tumors, even small ones, during the procedure and to approach them in a very targeted way to maximize the therapeutic outcome, while avoiding the destruction of healthy liver tissue. OncoSuite is designed to help us see, reach, and treat liver cancer in a better way.”
SIRT Users’ Network Announces European Expansion
The SIRT Users’ Network (SUN) was established by academics and clinical experts in the United Kingdom in 2014 in response to selective internal radiation therapy (SIRT) with radioactive yttrium-90 microspheres becoming available to patients with cancer via national health service commissioning. The SUN announced this year that it will expand to include health professionals from the United Kingdom, Belgium, Spain, and Italy. The cooperation amongst cancer specialists, radiologists, medical physicists and other professionals involved in delivering this highly specialist service aims to improve the treatment of patients with cancer. The network has an academic focus and is independent of commissioning and service considerations. The SUN website has a secure “members’ only” discussion forum to allow clinicians to hold private and secure exchanges of views on all aspects of the SIRT procedure and clinical issues. The site also provides freely available resources for clinicians and patients. The SIRT Users’ Network can be accessed at http://www.sirt.org.uk.
Surefire Infusion System Reaches Critical Milestone in Germany
Surefire Medical, Inc. announced that the German Institute of Medical Documentation and Information (DIMDI) has issued a unique classification code (OPS) for the Surefire Infusion System, which will allow the governmental organization to track and measure the use of Surefire technology in German hospitals. The issuance of this code marks the first step to obtain a specific diagnosis-related group (DRG) code and the appropriate reimbursement for Surefire products in Germany. The new OPS code – 8-83b.k – specifically calls out the use of a catheter-based infusion system with dynamic, expandable tip for selective embolization.
Liver Cancer Treatment Using Surefire Technology Results in 92% Objective Response Rate
At the 2016 Cardiovascular and Interventional Radiological Society of Europe Annual Scientific Congress, Surefire Medical, Inc., announced the results of a multicenter registry in which the use of the Surefire Precision Infusion System to deliver therapy in the treatment of primary liver cancer (hepatocellular carcinoma or HCC) was associated with a 68% complete tumor response and 92% objective tumor response. The multicenter registry evaluated the use of Surefire Precision during transarterial chemoembolization (TACE) in 32 patients with 41 lesions. Among the institutions included in the study were Mt. Sinai Hospital, Piedmont Hospital, University of Southern California Medical Center, Georgetown University via MedStar Georgetown University Hospital, and the University of California at San Diego Medical Center.
“TACE procedures utilizing the Surefire Infusion System was shown to effectively deliver therapy to the tumor,” said Aravind Arepally, MD, Chief Scientific Officer for Surefire Medical, in a press release. “The objective response rate shown in this multicenter registry is considerably higher when compared to the average response rate we see in the literature.”
Surefire Medical is also conducting a 140-patient, randomized, controlled, multi-center study comparing the outcomes of Surefire to standard end-hole catheter for drug-eluting beads transarterial chemoembolization (DEB-TACE) treatments in HCC. The study, titled “Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes,” is currently enrolling patients and seeking new sites.
Data Supporting CHEMOSAT Presented at CIRSE
Results from 2 single-institution studies conducted in Germany of use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with liver metastases were presented as posters at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) 2016 annual meeting. The first study evaluated 7 patients with unresectable ocular melanoma liver metastases treated with CHEMOSAT. Twelve CHEMOSAT procedures were administered in total, with a median of 2 cycles per patient, and a range of 1 to 3. The objective response rate after 1-2 treatments was 71.4%. Investigators concluded that CHEMOSAT is safe to use in these patients and that significant downsizing of ocular melanoma liver metastases can be achieved with CHEMOSAT. The second study retrospectively evaluated patients with advanced disease from primary or metastatic cancers of the liver. The local response rate (stable disease or partial response) was 80%. Mean progression free survival was 3.2 months. The investigators reported no major complications and that bone marrow suppression was common but controllable. The investigators concluded that patients with primary or secondary liver tumors that have disease progression under standard therapy might profit from percutaneous hepatic perfusion with Melphalan, that technical execution is problem free, and that complications are manageable.
Treatment Results of SIR-Spheres Y-90 Resin Microspheres Similar Regardless of Patient Age, New Publication Shows
A new analysis of the MORE data on 606 mCRC patients treated with SIR-Spheres yttrium-90 (Y90) resin microspheres at 11 US medical centers confirms that patient age is not a barrier to appropriate treatment with SIR-Spheres Y90 resin microspheres. The patient were divided into 2 groups, 446 patients under age 70 years at the time of treatment (younger group) and 160 patients age 70 years or older when treated (elderly group). Researchers also separately analyzed the data for 90 patients who were age 75 and above (very elderly group). The elderly patient group was more likely to have liver metastases that did not occur at the same time as their primary tumor or to have undergone previous surgery for their primary tumor (P=.009). Elderly patients also tended to have received fewer lines of chemotherapy treatment (P=.036) or no previous chemotherapy (P<.001) and were likely to have experienced a longer period of time between diagnosis and radioembolization (P=.011). In addition, the older patients were less likely to have received more than one radioembolization procedure. Overall survival was statistically the same (P=.335) between the older (9.3 months) and younger patients (9.7 months). There were also no age-related differences for any grade of adverse event (P=.433), including the more serious or grade 3+ events (P=.482) within 90 days of treatment.
Merit Medical Sponsors Educational Session at Clinical Interventional Oncology Symposium
Merit Medical Systems, Inc. participated at the 2016 Symposium on Clinical Interventional Oncology (CIO) in Hollywood, Florida. Merit sponsored a Mid-Day Industry Session, “Transradial Interventional Oncology: Mastering the Technique,” with Darren Klass, MD, PhD, serving as faculty presenter. The session introduced techniques and rationale for the use of the radial approach during interventional oncology procedures. Dr. Klass is a leading educator on the radial approach for interventional radiology and clinical oncology, having performed over 500 radial cases to date. He performed the first transradial radioembolization and chemoembolization of the liver in Canada, and is currently in the development of a hardware platform for radial access to the liver. CIO attendees also had the opportunity to gain hands-on experience with radial access for peripheral medical devices with Merit’s vascular training model, which replicates the introduction of interventional devices into the vascular system from several access points, including the radial artery.
Boehringer Ingelheim Starts First Patient Study With Bi-Specific Nanobody in Oncology
Ablynx announced that Boehringer Ingelheim administered the first dose in a Phase I dose escalation study with the half-life extended bi-specific anti-VEGF/Ang2 nanobody in adult patients with advanced solid tumors, triggering an €8 million milestone payment to Ablynx. The aim of the study was to evaluate the safety profile and dosing schedule for this nanobody. The anti-VEGF/Ang2 nanobody was discovered and developed as part of the strategic alliance between both parties, signed in September 2007. This nanobody blocks vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang2), important proteins involved in the formation of new blood vessels from pre-existing vessels (angiogenesis), a vital mechanism in the growth of tumors. The results from the preclinical study demonstrated that this bi-specific nanobody potently inhibits VEGF and Ang2 signaling in multiple in vivo cancer models and strongly impairs proliferation and survival of human endothelial cells. In addition, it showed superior efficacy as compared to inhibition of the individual pathways by the reference monoclonal antibody drugs. The nanobody was also found to be well tolerated in cynomolgus monkeys.
First Patient Treated With LC Bead LUMI Radiopaque Embolic Bead Supported by Philips Live Image Guidance
BTG plc, a global specialist healthcare company, and Royal Philips announced a significant milestone in their collaboration with the treatment of the first liver cancer patient with LC Bead LUMI in conjunction with Philips Live Image Guidance, targeting a hypervascular tumor with the goal to block blood flow to achieve tumor necrosis. This treatment, performed for the first time at the NIH Center for Interventional Oncology in Bethesda, Maryland, allowed visualization of embolic beads during interventional procedures for inoperable tumors, which allows clinicians to evaluate the completeness of tumor treatment and deliver treatment to liver tumors with more confidence. By enabling visualization of beads during an embolization procedure, LC Bead LUMI will help embolization technology achieve its full potential. LC Bead LUMI was cleared for clinical use in the United States in December 2015 after extensive laboratory testing based on the clinical foundation of its predicate device, LC Bead.
Medtronic Expands Pain Therapies Portfolio With the Launch of OsteoCool RF Ablation System
Medtronic plc announced US Food and Drug Administration (FDA) 510(k) clearance and US launch of the OsteoCool RF Ablation System. For physicians who treat patients with painful spine metastases, the OsteoCool System is the only cooled radiofrequency (RF) ablation technology that offers simultaneous, dual-probe capabilities, providing procedural flexibility and predictable, customized treatment. Cooled RF ablation uses targeted high-frequency energy to destroy cancer cells. Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further innovate the system. The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure. The 17-gauge, bipolar probes are available in three lengths and may be used through a variety of cannula sizes. Because two OsteoCool RF ablation probes can be used simultaneously, the system supports a variety of ablation scenarios accommodating unique patient and procedural needs.
First Patient in United States Treated With Elekta Leksell Gamma Knife Icon
Elekta announced that its Leksell Gamma Knife Icon, the most precise stereotactic radiosurgery system currently available, was used for the first time in the United States on March 1 at Sutter Medical Center, Sacramento Gamma Knife Center to treat a 52-year-old male patient with a metastatic brain tumor. The patient had previously undergone successful treatment for primary melanoma and for melanoma metastases to his lung. The patient’s treatment was planned and guided using the frameless mask solution, one of several new features of Icon, integrated with a novel high definition motion management. The system provides accuracy similar to that of frame-based SRS systems while minimizing dose to normal tissue. The system will make cranial SRS available to more patients and improve the efficacy of cranial SRS with fewer side effects.
Nanotechnology Lab Opens in Florida to Research, Apply Minute Materials to Cancer Care
With support from the state of Florida, Mayo Clinic’s Florida campus has opened a state-of-the-art laboratory for nanotechnology research. The laboratory is a key part of Mayo Clinic’s new Translational Nanomedicine Program. The goal is to develop, test, and apply tiny materials in diagnosing and treating patients, particularly those with cancer. Findings made in the lab will help expand and enhance cancer research. The lab will be directed by Debabrata (Dev) Mukhopadhyay, PhD, a world-renowned scientist in cancer and nanotechnology. He was recruited to Mayo Clinic to open the lab with a $2 million grant from the state of Florida. Dr. Mukhopadhyay has a broad background in tumor microenvironment, nanomedicine, and vascular biology. He has training and expertise in cancer, cardiovascular diseases, diabetes, and angiogenesis.
BTG Announces US Launch of LC Bead LUMI Radiopaque Embolic Bead
BTG plc announced the launch of LC Bead LUMI in the United States, the first commercially available radiopaque embolic bead for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). LC Bead LUMI is a next-generation development of the LC Bead embolic bead. The unique visibility of LC Bead LUMI during and after embolization supports the optimization of patient treatment by enabling real-time visible confirmation of bead location during the procedure. This provides interventional radiologists more control, while at the same time facilitating discovery of regions of under-treatment, allowing precise evaluation of the completeness of tumor treatment and enhanced endpoint determination, with long-lasting radiopacity to support follow-up management.
BTG to Initiate Multicenter TARGET Study Evaluating Dosimetry for Y90 Radioembolization Therapy in Patients With Hepatocellular Carcinoma
BTG plc announced plans to initiate the TheraSphere Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment (TARGET). The study evaluated 2-compartment dosimetry (normal tissue and tumor absorbed dose) in hepatocellular carcinoma patients in interventional oncology in an effort toward a more personalized approach to Y90 radioembolization therapy for liver cancer patients. The primary endpoint of the study was to determine the correlation between the normal tissue absorbed dose, based on 99mTc-MAA, and ≥Grade 3 hyperbilirubinemia for patients administered TheraSphere. Secondary endpoints included tumor absorbed dose, incidence of serious adverse events, select dose related adverse events, clinical laboratory assessment, objective tumor response, and overall survival. BTG planned to initiate the study in July 2016 following IRB and EC approval in the United States and select countries in Europe and Asia.
BTG Acquires Galil Medical, a Leader in Cryoablation
BTG plc announced an agreement to acquire Galil Medical, a leading provider of cryoablation products for the treatment and palliative care of kidney and other cancers. Galil Medical is headquartered in Arden Hills, Minnesota. Galil Medical owns, manufactures, and sells a portfolio of cryoablation systems and needles. The systems use compressed argon gas to produce extremely low temperatures; as the gas passes through the needle, the tip of the needle is cooled, forming an ice ball. The ice ball engulfs the tumor and destroys the tissue. In the United States, Galil Medical’s products are indicated for the treatment and palliative care of kidney and other cancers, in addition to a number of other uses, including in urology.
Olympus Improves Specimen Sample Size for More Targeted Therapy in Lung Cancer
Olympus announced the introduction of its 510(k) cleared ViziShot FLEX 19G EBUS-TBNA Needle, used in Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA). EBUS uses a bronschoscope equipped with ultrasound capabilities to “see” beyond the walls of the airways and detect diseased tissue, lymph nodes, or lesions. Suspect lymph nodes can then be sampled using a special aspiration needle. This new needle provides a larger sample size, which can provide more material for molecular biomarker testing, potentially leading to more targeted therapy for the patient. The ViziShot FLEX 19G is the largest EBUS-TBNA needle on the market. Benefits of this new needle include larger sample size, increased safety with a double-locking mechanism, and proven track record, all of which leads to enhanced patient satisfaction, decreased costs, and better quality of care.
Misonix Features New BoneScalpel MIS at SpineWeek 2016 in Singapore
Misonix, Inc. exhibited at the 2016 SpineWeek conference in Singapore, which took place from May 16 to May 20, 2016. Surgeon attendees at this global conference had the opportunity to trial the BoneScalpel, and the newly launched minimally invasive spinal solution BoneScalpel MIS, in a hands-on session at the exhibition. Scott Ludecker, Senior Vice President of Global Sales & Marketing, commented, “Advancements like BoneScalpel MIS are enabling minimally invasive spine procedures that have less postoperative pain, are safer, and potentially return patients to their normal activities sooner than otherwise possible with open procedures. Additionally, the BoneScalpel MIS has been referred to as a ‘game changer’ by a number of opinion leading surgeons and continues to gain acceptance around the world. Participation in SpineWeek this year will serve as a great forum for Misonix to continue its growth into the Asian markets.”
Radiofrequency Ablation an Effective Alternative Treatment for Adrenal Neoplasms
Researchers reinforced radiofrequency ablation (RFA) as an effective and safe alternative to adrenalectomy in the treatment of benign and malignant adrenal gland tumors.
“Radiofrequency ablation is a safe and effective procedure to treat adrenal tumors in patients who are poor surgical candidates or refuse adrenalectomy,” said Lima Lawrence, MD, a member of the team that shared its RFA case study findings at the American Association of Clinical Endocrinologists (AACE) 25th Annual Scientific & Clinical Congress media briefing. “Although it offers patients a minimally invasive option for treating focal adrenal tumors, properly designed randomized controlled trials are needed before incorporating RFA into the standard of care for adrenal tumors.”
A procedure that traditionally has been performed under ultrasound or computed tomography (CT) guidance for patients with various cancers such as liver, lung, kidney, and bone, the treatment of adrenal tumors using radiofrequency ablation (RFA) has been a more recent option for patients unable to undergo surgical intervention. RFA has been shown in various studies to resolve abnormal biochemical markers and clinical symptoms caused by adrenal tumors.
CARTI Installs First Toshiba Infinix 4D CT to Seamlessly Integrate IR and CT
Cancer patients at the CARTI Cancer Center now have access to a new innovation in diagnostic imaging with Toshiba America Medical Systems, Inc.’s Infinix 4D CT. The CARTI Cancer Center is the first health care facility in the United States to install the Infinix 4D CT and its unique merging of the Infinix-i angiography system and Aquilion ONE ViSION Edition CT system that may help clinicians improve visualization and work flow and increase patient safety. CARTI is utilizing the system for interventional radiology and oncology to plan, treat, and verify in a single clinical setting. Real CT imaging available on demand may help interventionalists improve visualization of tumors and feeder vessels, as well as provide whole organ body perfusion, to help them not only plan and treat but also verify their procedures.
Elekta’s Leksell Gamma Knife Icon Cleared for Use in Japan and United States
The Japanese Ministry of Health, Labor, and Welfare and the Nuclear Regulatory Commission in the United States have cleared Elekta’s Leksell Gamma Knife Icon for clinical use. Icon is a sophisticated system for radiosurgery treatment of certain brain tumors, vascular malformations, and functional disorders. The system offers physicians increased flexibility by allowing either frame-based or frameless methods to immobilize the patient’s head, while ensuring the highest level of precision. It opens a new paradigm in cancer care for patients with larger brain tumors and lesions close to critical brain structures to be treated with Gamma Knife accuracy and confidence. Leksell Gamma Knife Icon received 510(k) approval from the US Food and Drug Administration in August 2015 and CE marking in June 2015. Icon’s integrated stereotactic cone-beam CT (CBCT) imaging technology checks the patient’s position against the treatment plan and automatically recalculates the plan to correct for movement, thus ensuring the highest precision. During treatment, Icon’s novel HD motion management system manages patient movement by using infrared marker tracking to monitor cranial position.
Philips Teams Up With Leading Innovators in Interventional Oncology
Royal Philips (NYSE: PHG, AEX: PHIA) announced that as part of the existing Master Research Agreement with Yale School of Medicine, it has entered into a new research program led by Prof. Jeff Geschwind, chair of Radiology and Biomedical Imaging at Yale School of Medicine, to innovate in interventional oncology. Philips will collaborate with Prof. Geschwind and his team on a multiyear cancer research program to explore new concepts in image-guided therapies, as well as diagnostic imaging and informatics. The research program also involves further research groups at Yale School of Medicine. Prof. Geschwind is a pioneer in interventional oncology, and following his recent appointment at the Yale School of Medicine, he has built an ambitious, comprehensive research program in cancer diagnostics and image-guided therapy. As part of the research agreement, a dedicated team of Philips clinical scientists will be working closely with Prof. Geschwind’s team at the Yale School of Medicine in a recently established state-of-the-art research facility optimized to translate laboratory results into enhanced patient care.
Merit Medical Acquires DFINE, Inc., Manufacturer of RFA Tool for Metastatic Spinal Tumors
Merit Medical Systems, Inc. (NASDAQ:MMSI) announced that it has acquired DFINE, Inc., headquartered in San Jose, California, in a merger transaction through which DFINE has become a wholly-owned subsidiary of Merit. DFINE’s products are directed to vertebral augmentation (kyphoplasty and vertebroplasty), as well as targeted radiofrequency ablation of metastatic spinal tumors. DFINE’s product lines have 510(k) clearance and CE marking.
New SIRFLOX Analysis Shows Patients with Colorectal Cancer Liver Metastases Had Significantly Greater Depth of Tumor Response to SIR-Spheres Y90 Resin Microspheres
New data presented by Prof. Dr. Volker Heinemann in an oral abstract session at the European Society of Medical Oncology’s 18th World Congress on Gastrointestinal Cancer suggest that patients with liver-dominant mCRC treated first-line with the combination of mFOLFOX6 and SIR-Spheres Y90 resin microspheres in the recently published SIRFLOX study experienced a much more profound response to treatment in the liver than those who received chemotherapy alone. According to depth of response (DpR) analysis, a relatively new methodology that has been shown to correlate with overall survival (OS) and post-progression survival in earlier mCRC studies, there was a significantly greater DpR (75.0% vs 67.8% mean reduction in liver tumor burden; P=.039) in patients who received SIR-Spheres Y90 resin microspheres combined with chemotherapy. Patients also had a statistically significant, 2-month longer time to DpR or maximal tumor shrinkage (median 266 vs 206 days; P<.001), compared to those who received chemotherapy alone.
BTG Announces Successful CE Mark Reclassification for DC Bead to Class III Based on Its Ability to Administer Medicines
BTG plc announced that it has obtained European Conformity (CE) Mark from the Notified Body British Standards Institution (BSI) following completion of the reclassification of DC Bead and DC Bead M1 as Class III medical devices under Rule 8 of Annex IX to Directive 93/42/EEC. The assessment takes account of the characteristics of DC Bead and DC Bead M1 with regard to their ability to administer medicines and the product-specific nonclinical and clinical data supporting the safe and effective conditions for use of DC Bead in the approved clinical setting. The conformity assessment procedure has resulted in clear indication statements to permit use of DC Bead and DC Bead M1 as Class III medical devices in transarterial chemoembolization for the treatment of liver tumors. DC Bead and DC Bead M1 are embolic drug-eluting beads capable of loading and releasing compatible chemotherapeutic agents. They are manufactured using a unique, patent-protected polymer and supported by a clinical data package comprising safety and clinical performance data in over 3,000 hepatocellular carcinoma (HCC) patients and over 600 patients with liver metastases from colorectal cancer.