BB&T European Editor and Staff Reports

Masimo (Irvine, California) last month said it received both Japanese Ministry of Health Labor & Welfare (MHLW) and Health Canada regulatory clearances of the Pronto-7 – enabling clinicians tin those countries to measure total hemoglobin (SpHb), SpO2, perfusion index, and pulse rate without removing a drop of blood.

According to the company, Masimo SpHb provides immediate real-time hemoglobin results that enable clinicians to more rapidly assess patients and detect and treat internal bleeding and low hemoglobin conditions earlier. And, although Masimo noninvasive and continuous total hemoglobin (SpHb) monitoring – commercially available in both Japan and Canada for over a year – is the preferred technology for hospitals and inpatient care centers due to its ability to provide continuous SpHb measurement, access to quick and easy spot-check hemoglobin measurements are valuable for a variety of healthcare assessment applications, including physician offices, outpatient care centers, and pre-hospital emergency settings.

The company said the palm-sized, handheld Pronto-7 offers a breakthrough solution for measuring total hemoglobin, SpO2, perfusion index, and pulse rate in less than one minute without the needles, time-consuming laboratory analysis, risk of blood contamination, hazardous medical waste, and patient discomfort associated with traditional blood tests. With dimensions of just 13 cm x 7.2 cm x 2.5 cm (5.1“ x 2.8“ x 1“) and weight of 296 grams (10.5 ounces), the Pronto-7 puts the power of noninvasive hemoglobin spot-check testing, along with SpO2, perfusion index, and pulse rate into any clinician's hands in various clinical settings — including physician offices, hospitals, clinics, and on the scene of medical emergencies.

In addition to Normal Mode, Pronto-7 offers Max Sensitivity Mode that allows measurement over a broader range of patients and three noninvasive sensor sizes to accommodate the range of finger diameters. Each sensor is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White) and optimized to improve performance in low ambient temperatures. And, because of the device's embedded 802.11 b/g and Bluetooth communication capability, wireless printing or emailing of test results is enabled with future upgrades that will allow for wireless transmission to electronic health record systems.

Prior to the introduction of the Pronto-7 internationally, Masimo received FDA 510(k) and CE mark clearance and first introduced the ability to noninvasively and continuously measure SpHb in 2008 using its Radical-7 bedside Pulse CO-Oximeter. In 2009, Masimo launched Pronto — its first handheld noninvasive spot-check device for total hemoglobin, SpO2, perfusion index, and pulse rate measurements. And in 2010, Masimo established Medicare reimbursement for transcutaneous hemoglobin measurement in the U.S.

As part of Masimo's verification process, more than 11,443 Pronto-7 measurements were performed on 1,445 subjects at 14 sites and compared to hemoglobin measurements from a venous blood sample analyzed on a hematology analyzer (Coulter Counter). This testing resulted in a product specification of 1.0 g/dL for normal sensitivity mode. While not a regulatory requirement, Masimo elected to perform additional testing on Pronto-7 devices and sensors produced at a Masimo manufacturing facility. This additional testing included 474 subjects in three outpatient clinic-type environments. The hemoglobin measurements from the Pronto-7 and a point of care device using capillary blood (Hemocue) were compared to hemoglobin measurements from a venous blood sample analyzed on a Coulter Counter. The Pronto-7 showed a bias of was -0.1 g/dL and a standard deviation of 1.1 g/dL, while the Hemocue showed a bias of -0.1 g/dL and a standard deviation of 1.6 g/dL.

OptiMedica wins CE mark for Catalys

OptiMedica (Santa Clara, California) has received CE mark for its Catalys Precision Laser System for cataract surgery in Europe. The company says the system combines a femtosecond laser, integrated Optical Coherence Tomography imaging and OptiMedica's pattern scanning technology in an ergonomic, easy-to-use system designed to bring new levels of precision and accuracy to the cataract procedure.

Mark Forchette, president/CEO of OptiMedica, told BB&T that he was at a facility the other day that happened to be the same facility where he first saw a cataract surgery performed 27 years ago. “I don't know that in that 27 years I've seen anything like this kind of reset in the cataract procedure . . . it makes you reconsider everything,“ he said.

The company noted that while there have been incremental advancements in surgical tools and techniques in recent decades, the conventional procedure still requires physicians to perform several critical steps manually. This manual approach limits predictability and precision, potentially affecting refractive outcomes and complication rates.

“This is an outstanding day for patients, physicians and for OptiMedica,“ Forchette said. “We believe that the field of cataract surgery is in the midst of a revolutionary change, and we expect Catalys to provide leading technology that satisfies the high expectations of surgeons and their patients. Our system's CE mark approval is a huge achievement made possible by the efforts of OptiMedica's dedicated and talented team of scientists, engineers and medical advisors to develop and bring this breakthrough innovation to market. We are excited to enter this new stage in OptiMedica's history, and we look forward to introducing Catalys to markets around the world in the very near future.“

With Catalys, physicians have the opportunity to perform cataract surgery with an unsurpassed level of accuracy, OptiMedica says. The system is now CE mark approved to deliver capsulotomy (a circular incision in the lens capsule) and lens fragmentation (segmenting and softening of the lens to prepare for removal), with CE mark approval for corneal incisions anticipated in the near future. A clinical study has demonstrated that Catalys delivers marked improvement over manual surgical technique, with key metrics including:

Capsulotomy size, as measured by deviation of capsule diameter from intended target. The average deviation in capsule diameter with Catalys was only 29 microns, as compared to an average deviation in the manual technique of 337 microns;

Capsulotomy shape, with a score of 1.0 representing perfect circularity. Capsulotomies delivered with Catalys achieved almost 95% circularity, with very little spread in outcomes across all eyes. In the manual group, only 77% circularity was achieved, with a larger spread in results;

Capsulotomy centration. Capsulotomies performed with Catalys were within only 77 microns of perfect centration relative to the dilated pupil; and,

Ease of lens fragmentation and disassembly. With Catalys, cumulative dissipated energy (CDE) during ultrasound phacoemulsification was reduced by nearly 40%.

OptiMedica expects to ship its first Catalys system in Europe in 4Q11.

Forchette said the biggest challenge OptiMedica is faced with right now is “managing the levers“ and meeting the high demand for the product while also making sure it's right when customers get their hands on it.

“Having had a really wide footprint with PASCAL [PAttern SCAn Laser], we know what that feels like and we would like to get there – and customers want us to get there,“ Forchette said. “So the challenge is just making sure that we get this product in the hands of customers – at the speed at which they want it – all over the world, and not only getting it to them quickly but we've got to get it to them right. I realize that this is a significant investment that each customer will make and we need to make sure that we treat it that way.“

OptiMedica says it developed the Catalys system in close collaboration with a medical advisory board of cataract experts from around the world, with the shared objective to deliver unprecedented accuracy and an exceptional experience. Key innovations reflecting this objective include a Liquid Optics Interface that ensures stable system-patient attachment and optimizes the optical path to the patient's eye, and a proprietary Integral Guidance system that ensures the femtosecond laser pulses are delivered safely and precisely to the intended location. In addition, the system features an easy-to-use and elegant graphical user interface designed to simplify the planning process and minimize the time the patient is under the dock.

“Stuff like this doesn't happen by chance,“ Forchette told BB&T. “We have a brilliant group of engineers and technical people at OptiMedica who have been obsessing over this, but we've also had physicians and nursing staff involved through the whole process. We've had our medical advisory board deeply ingrained in the development . . . that was really important in the product being as good as it is because it made us consider all the different needs and I believe we've been able to meet or exceed those needs.“

MedWaves gets KFDA certification for AveCure

MedWaves (San Diego) reported that it has received receipt of Korean Food and Drug Administration (KFDA) Certification to import and sell its AveCure microwave ablation (MVA) system and devices through its distribution partner in South Korea.

The AveCure MVA system uses microwave energy to volumetrically coagulate-ablate soft-tissue lesions. The system has successfully treated more than 1,000 patients worldwide, including lesions in bone, kidney, liver, lung and pancreas.

The company said it plans to bring its technology to treat lesions in other locations in the body. Its technology makes available treatment options for many cancer patients in either early or late stage and helps those who are running out of options.

South Korea, with 48.5 million in population, is an important market for MedWaves. Cancer is the leading cause of death in South Korea, and the company said it is pleased to receive KFDA approval to import and sell products. MedWaves said it is in close coordination with its South Korean distributor-partner in scheduling and conducting clinical evaluations for sales of its AveCure system in key South Korean hospitals.

Solta's Clear + Brilliant gets Canadian approval

Solta Medical (Hayward, California) in September reported Health Canada approval of its new Clear + Brilliant laser aesthetic treatment. This technology is now available to physicians in Canada. In May, the company received FDA 510(k) clearance and the CE mark to market and sell Clear + Brilliant. This treatment is an effective treatment based on fractional laser technology that is performed in a professional setting, the company said.

The launch of Clear + Brilliant creates and defines an entirely new category of laser aesthetic treatments designed to attract younger patients looking to take control of their aging process. The company said that Clear + Brilliant provides a new offering for physicians and skin care providers to address evolving consumer needs and expand their patient base.

Unlike other conventional lasers that utilize the stamping delivery method, Clear + Brilliant features a patented Intelligent Optical Tracking System that the company claims provides consistent coverage and insures a uniformly toned treatment area.

Angioslide launches new SFA device

Angioslide (Caesarea, Israel) has launched its new 5x300 mm Proteus device for treating the superficial femoral artery (SFA). Proteus technology combines a percutaneous transluminal angioplasty (PTA) balloon and embolic capture of particles in one device.

The new 5x300 mm size joins Angioslide's product line solutions for the lower limbs. According to the company, the new device makes it possible to treat lesions up to 300 mm with one device, while providing immediate solution for embolic capture.

Initial treatments using the new Proteus device were conducted in leading world centers, Parkkrankenhaus Leipzig and Herzzentrum Bad Krozingen, in Germany.

“Angioslide's breakthrough technology, now available also in 300 mm length as well, is a unique solution for lesions with high level of embolic material, including chronic total occlusions (CTO), in stent-restenosis, thrombus containing lesions and post atherectomy PTA,“ said Thomas Zeller, head of the Angiology Department at Heart Center Bad-Krozingen.

With the increase in life expectancy, diabetes prevalence, and number of high-risk patients, together with the shift toward an endovascular-first approach as a preferred procedure over surgical revascularization, there is a growing need for expanding the current interventional tool box to accommodate procedures designed specifically to treat long and diffuse lesions in a quick and effective manner, the company noted.

The device is currently released for the European market only, and is under review with the FDA.

Mela Sciences receives CE mark for MelaFind

Mela Sciences (Irvington, New York) in September said it received CE mark approval for MelaFind, allowing the company to market its MelaFind device to dermatologists across the European Union. The company says it will initially market MelaFind in Germany, which has the highest incidence of melanoma in Europe.

“We're extremely pleased to receive the CE mark for MelaFind,“ said Joseph Gulfo, MD, president/CEO of Mela Sciences. “With more than 81 million people, Germany represents a significant opportunity for the company and an ideal market to launch MelaFind in the EU. Given the high rates of melanoma seen in the German population, we believe MelaFind has the potential to make a deep impact on the disease there. In order to achieve our initial goals for the commercial development phase of the launch, we plan to utilize a direct sales force that will focus on strategically placing MelaFind systems in the top dermatology practices in several key cities throughout the country.“

Melanoma rates in Germany have doubled over the last decade and the national mortality rate from the disease is the highest in Europe. Over 20,000 Germans are expected to be diagnosed with melanoma by 2016. Germany is the only country in the world with a nationwide skin screening effort in place for men and women age 35 and older.

The clinical data for the CE mark application were submitted in May and the complete technical file was submitted in early July.

“We are very impressed with the process in obtaining EU regulatory approval, which included an extensive audit of our facilities,“ Gulfo said. “We enjoyed frequent, straightforward and transparent interactions with European reviewers leading up to application submission and throughout the review process.“

The studies used to support the CE mark application included a 1,383-patient U.S. pivotal trial and the companion reader study of 110 dermatologists. The device demonstrated a 98% sensitivity whereas dermatologists had a 72% sensitivity in the companion reader study. Mela Sciences worked with the FDA to design the pivotal study, the largest ever conducted in melanoma detection, and has a binding protocol agreement with the agency. Nearly 11% of all lesions and melanomas in the MelaFind database were obtained from European clinical sites.

In the U.S., Mela Sciences submitted a PMA application for MelaFind in June 2009, and received a positive panel vote at an advisory committee meeting in November 2010. The company is currently still awaiting the FDA's decision. Gulfo has publicly expressed frustration with what the company considers “undue delays“ in getting its MelaFind PMA approved and last year the company filed a citizen's petition because of it.