ELA Medical (Le Plessis Robinson, France), a Sorin Group (Milan, Italy) company and a leader in the development of cardiac rhythm management (CRM) implantable and diagnostic systems, has reported the European introduction of its Ovatio implantable cardioverter defibrillators (ICDs). An ICD can prevent sudden cardiac arrest, the leading cause of death in Europe with an estimated 400,000 deaths annually.
The new family of ICDs includes both dual-chamber (Ovatio DR) and a single-chamber (Ovatio VR) models. ELA Medical said the Ovatio devices are the world’s smallest ICDs, weighing 29 cc and measuring just 11 mm “thin,” as the company characterizes it.
The “physiologically-shaped” ICDs also offer 34 joules of maximum output, which ELA Medical said is useful for patients whose defibrillation threshold is particularly high and who may require more energy to terminate life-threatening arrhythmias.
The Ovatio ICD family also includes features dedicated both to pacing and arrhythmia management and advanced diagnostic features that offer what the company termed “significant patient benefits.” The dual-chamber Ovatio DR includes AAIsafeR and PARAD+. AAIsafeR is ELA Medical’s pacing mode, limiting unnecessary stimulation in the right ventricle, which the company said prevents onset and progression of heart failure.
With the AAIsafeR mode, the ICD continuously monitors a patient’s intrinsic atrioventricular (AV) conduction and delivers ventricular pulses only when necessary. Studies have shown that AAIsafeR reduces the amount of ventricular pacing to less than 0.2% in ICD patients with intrinsic conduction, while according to the company, conventional dual-chamber ICDs “unnecessarily pace this patient population 50% of the time.” The patient’s AV conduction can fully be documented through detailed statistics and intracardiac EGMs.
Ovation DR’s PARAD+ (P And R Arrhythmia Detection) ventricular arrhythmia detection software protect patients from inappropriate shocks that may result from misclassified supraventricular tachyarrhythmias (SVTs). ELA Medical said PARAD+ is “the most specific ventricular arrhythmia detection software available to patients worldwide today.”
While SVTs have been reported to trigger 55% to 69% of inappropriate shocks, the company said PARAD+ demonstrated a 99% overall specificity with out-of-the-box settings in a recently published study.
Ovatio DR also is capable of detecting and treating the full spectrum of tachyarrhythmias through painless anti-tachycardia pacing (ATP). The device has the capability to terminate the slowest (100 bpm) as well as the fastest (up to 255 bpm) ventricular tachyarrhythmias.
The first post-launch Ovatio implant was performed at the Medizinische Klinik und Poliklinik (Heidelberg, Germany) by Alexander Bauer, MD. The recipient was an 82-year-old woman who suffered from ischemic cardiomyopathy. Bauer said the implant procedure “went very smoothly. The shape and size of Ovatio VR made it easy to implant. Programming the ICD was also extremely simple.”
To make post-implant office visits faster, Ovatio ICDs are supported by a new programming software that the company said is 10 times faster than previous versions.
Andre-Michel Ballester, president of the Sorin Group’s Cardiac Rhythm Management business unit, said the Ovatio introduction “reflects [our] drive to develop cutting-edge tachyarrhythmia management systems that are capable of respecting the heart’s natural rhythm and bringing significant patient benefits.” He added: “Although Ovatio ICDs are technologically sophisticated devices, they have been designed to simplify implant and follow-up procedures.”
Lumenis gets Korea, Taiwan approvals
The South Korean FDA has granted Lumenis (Yokneam, Israel) approval for its Lumenis One laser device, opening up the aesthetic laser and light device market in South Korea and Taiwan, estimated at more than $38 million and expanding rapidly, with skin treatments driving the growth.
Along with the marketing approval has come an import license from the Taiwan Ministry of Health.
President and CEO Avner Raz said, “The launch of our popular Lumenis One into Korea and Taiwan will further strengthen Lumenis’ position as the leading aesthetic system supplier in the Asia region.”
Raz added: “We are pleased that the clinical efficacy and product safety of our flagship Lumenis One aesthetic system has once again been stringently reviewed and publicly validated. Our Lumenis One provides practitioners leading-edge technology to address the vast majority of their aesthetic treatment needs in one sophisticated platform – better for their patients and their practice.”
Qiying Zhai, Lumenis’ vice president for China and Asia Pacific, said, “We are confident that Lumenis One will be as well received in Korea and Taiwan as it has been elsewhere in the region, where physicians report very safe and effective treatments on Asian skin, and we find that the demand for Lumenis One is growing steadily.”
Lumenis One is a multi-technology, multi-application and upgradeable platform designed for comprehensive aesthetic treatments. The platform combines several proprietary technologies into a single modular and customizable system: IPL (Intense Pulse Light) for skin rejuvenation and treating vascular and pigmented lesions, LightSheer diode laser for hair removal, Multi-Spot Nd:YAG laser for deeper vascular lesions and leg veins, and the recently introduced Aluma for predictable and virtually pain-free skin renewal.
The system’s key features include Optimal Pulse Technology (OPT), numerous pre-set settings that can easily be customized and an intuitive touch-screen software interface. These combine to provide not only greater patient comfort and faster treatments, but readily recorded, repeated and tracked patient treatment histories.
Raz said that global markets have high importance in the company’s turnaround plan and reorganization, initiated last year to correct flaws that knocked Lumenis into Pink Sheet trading.
Raz indicated that the company is striving not only to boost financials and bring about greater efficiency, but also overwhelming customer satisfaction among both practitioners and patients.
“Improvements have been made in operational efficiencies, margins and expenses, which resulted in solid operating profits and continued positive cash flow, demonstrating the benefits of our new organization and operating model, while remaining firmly committed to new product development,” he said.
Raz noted a growing backlog of orders for Lumenis One, which received regulatory approval in June 2005 from the State Food and Drug Administration (SFDA) of China. By that date, Lumenis had sold more than 500 IPL Quantum systems in the Asia Pacific region, which consists of all of Asia outside of Japan.
He added that in the broadly defined future goals, “by leveraging our global infrastructure, we also intend to drive growth and profitability in all of our markets.”
One market segment in particular is glaucoma. In October, Lumenis announced the sale of the one-thousandth Selecta SLT Laser for selective phototherapy of glaucoma, but Raz noted that “while adoption of SLT in the US has been remarkably high, Lumenis also has identified and will pursue the untapped markets in Asia Pacific and Europe.”
He cited available estimates suggesting that there are 70 million glaucoma patients worldwide, and open-angle glaucoma is the most common form of this condition. Only 3 million of these glaucoma patients are in the U.S., and the incidence of glaucoma is expected to increase worldwide as the global population ages. “We are uniquely positioned to address this growing global need,” Raz said.
Embolic delivery products okayed in China
BioSphere Medical (Rockland, Massachusetts), a developer of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, said its embolic delivery system products, the EmboCath Infusion Catheter and Segway Guidewire, have been approved by the Medical Device Department of the State Food and Drug Administration in China for use in embolization procedures.
In China, the company plans to sell both its delivery system products and its Embosphere Microspheres for embolization procedures. The use of Embosphere Microspheres for embolization is under review by the Chinese regulatory authorities based on a clinical trial using the microspheres in a treatment protocol for patients with primary liver cancer (hepatocellular carcinoma, or HCC).
BioSphere Medical said it expects market clearance for the use of Embosphere Microspheres during the first half of this year.
Richard Faleschini, president and CEO, said, “The approval of BioSphere delivery system products in China is part of our commitment to the growth of embolic therapies and is also an important step in our efforts to address the clinical needs of an estimated 350,000 patients in China with primary liver cancer.”
Liver cancer patients in China comprise roughly half of the total worldwide patient population. The incidence of primary liver cancer in Asia is attributed to a higher incidence of hepatitis B and C in the region. Many primary liver cancer patients are diagnosed at a level of tumor development where they are no longer good candidates for surgical intervention, and BioSphere Medical said many physicians believe that minimally invasive embolic therapy may be used to slow the advance of cancer in conjunction with other therapies.
Interventional radiologists deliver embolics to the site of service through the blood vessels with catheters threaded via guidewires under live imaging. EmboCath and Segway are approved for use in the U.S., Canada, the European Union and other countries.
Study boosts value of IORT
Intraop Medical (Sunnyvale, California) said that its Mobetron technology has received a major boost from a recent study, involving 1,018 patients, documenting the advantages of Intraoperative Radiation Therapy (IORT) to improve the treatment of early-stage breast cancer.
The study, hosted by six European cancer treatment centers and conducted by the International Society of IORT-Europe, followed the women post-IORT treatment for an average of 39 months. While more than half of the patients had one or more adverse factors, there were only three in-breast recurrences and only 38 patients developed further metastatic disease, according to the study.
The study results were presented in Salzburg at the Austrian Radiation Oncology Meeting by Dr. Felix Sedlymayer, professor and chairman of the Department of Radiation Oncology at the University of Salzburg.
Mobetron is a mobile, electron-beam system designed to deliver radiation to the tumor while the patient is undergoing cancer surgery (that is, via IORT).
Dr. Donald Goer, president and CEO of Intraop, said, “If we assume that these patients had been treated with conventional breast-conserving therapy without IORT, based on published literature, the results would have been quite different, and statistics show that one would have expected about 25 breast recurrences, and more than 65 of the patients would have developed metastatic disease.”
He added, “We look to this study as solid support for our marketing initiative. Our Mobetron offers all the advantages of IORT, with the significant advantage of being mobile and compact enough to fit right into the surgical environment.”
The five-year disease-specific survival rate of study subjects was 99.1%, and the five-year overall survival rate was 96.5%. At study’s conclusion 977 patients remained alive, without disease and with a preserved breast.
This was the first pooled analysis by the ISIORT-Europe on the clinical outcomes of patients treated with IORT, and ISIORT-Europe is planning a prospective randomized trial on anticipated IORT breast boost. It also plans to present the results of IORT on other tumor sites in the months ahead.
Recently, The Lancet also highlighted improved survival results of 42,000 early-stage breast cancer patients treated with techniques that increased local control in breast cancer.
Intraop bills the Mobetron as the first mobile device for delivering IORT in the OR without the need to add extensive radiation shielding. It is approved in the U.S., Europe, Japan and China.
BSD Medical nears accords for Japan
BSD Medical (Salt Lake City) reported that it is close to completing agreements with Japanese distributors in preparation for the company’s entry into that market with its BSD-2000 cancer treatment system. Noting that Japan is the world’s second-largest medical market behind the U.S., BSD said entry into that market is part of its global marketing strategy. The company said Japan, along with China, are two high-priority marketing targets in the Pacific Rim, representing a major percentage of the total Pacific Rim market.
BSD Medical already has a distributor in China, and obtained regulatory approval for the sale of the BSD-2000 in China earlier this year. Initial sales in China have been to four “highly visible” hospitals that the company said would serve as “important reference sites” in that market.
The company said its objective is to pursue a similar marketing path in Japan.
BSD Medical’s systems deliver precision-focused radio frequency/microwave energy to kill cancer directly and boost the effectiveness of companion radiation or chemotherapy treatments.
Enpath steerable sheath CE-marked
Enpath Medical (Plymouth, Minnesota) reported receiving CE-marking approval for its steerable sheath, used to facilitate placement of interventional devices in the peripheral, coronary and neurovascular systems. The approval enables its distribution partner, Bard Electrophysiology, a division of C.R. Bard (Murray Hill, New Jersey), to launch the product in Europe for electrophysiology (EP) applications.
“With [FDA clearance] received in July 2005, the European Union’s approval positions Enpath’s innovative steerable sheath for distribution in the two largest electrophysiology markets in the world,” said Jim Hartman, CEO and chairman of Enpath.
The Enpath steerable sheath features distal tip deflection for the precise placement of such devices as cardiac ablation catheters and peripheral stent delivery catheters. “The EP market is the first of a variety of clinical applications that can benefit from the use of our steerable sheaths,” Hartman said. “We are particularly excited by the potential for our proprietary steerable sheath technology to be used in the delivery of carotid artery stents and other peripheral vessel interventions, as well as for precision placement of implantable leads, and we are continuing to develop the device for these indications.”
Vasamed’s AcQtrac CE-marked
Vasamed (Minneapolis), a developer of non-invasive, hemodynamic assessment technology, reported receiving the CE mark for its new AcQtrac System which provides real-time measurements of hemodynamic parameters that allow physicians to manage a range of cardiovascular patients.
“Overall, heart disease is estimated to cost Europe EUR 169 billion annually,” said Paulita LaPlante, president and CEO of Vasamed. “The AcQtrac System’s rapid, non-invasive cardiovascular assessment can be a cost-effective alternative for a market focused on earlier diagnosis and treatment as part of their overall health policy objectives.”
FDA-cleared earlier this year, the AcQtrac relies on a graphical waveform that represents the mechanical function of the cardiovascular system and provides information to quickly assess conditions such as congestive heart failure or to monitor treatment outcomes such as those provided by drug therapy.
Vasamed also makes the SensiLase PAD 3000 and Laserdopp PV2000 System for quantitative evaluation of microcirculatory perfusion in patients with chronic foot ulcers, diabetes and other peripheral arterial disease. Laser Doppler technology, coupled with algorithms to measure skin perfusion pressure and pulse volume, assist in evaluating microvascular health.
Cerus seeks CE mark for Intercept
Cerus (Concord, California) reported submitting its application for CE marking of its Intercept Blood System for plasma in Europe. The system, being jointly developed by Cerus and Baxter Healthcare, is designed to reduce the risk of transfusion-transmitted diseases. It inactivates pathogens such as HIV, hepatitis B and C viruses, bacteria, and parasites that may be present in donated plasma intended for transfusion.
Claes Glassell, president and CEO of Cerus, called the filing “one more step in our plan to commercialize the Intercept Blood System for all three components: platelets, plasma, and red blood cells.”
While donated plasma is generally tested for a limited number of specific pathogens, testing does not eliminate the risk of viral or bacterial contamination. The Intercept for targets the nucleic acids of a broad spectrum of viruses, bacteria and other pathogens. Based on Cerus’ Helinx technology, the company says that Intercept “offers the potential to inactivate untested-for and emerging pathogens before they become a major transfusion risk to patients.”
Scottish screening program extends Cytyc pact
Cytyc (Marlborough, Massachusetts) said the Scottish Cervical Screening Program has extended the current national contract with Cytyc UK for the supply of Cytyc’s ThinPrep Pap Test to all Scottish laboratories. The exclusive contract is for an additional five years, which is estimated to represent 2.2 million ThinPrep Pap Test sales during that period.
Cytyc said the decision follows the successful national conversion from conventional pap smears to the ThinPrep Pap Test in Scotland begun in 2003.
It said that since implementation of the ThinPrep System, the Scottish Cervical Screening Program has noted a range of clinical benefits related to the product, including a reduction in the number of patient recalls due to unsatisfactory specimens and a steady reduction in turnaround time for reporting results. Each year more than 440,000 women participate in the Scottish Cervical Screening Program and 11 laboratories are responsible for processing the tests.