A Medical Device Daily

Medical Ventures (MEV; Richmond, British Columbia), a device company focused on products for the cardiovascular and surgical markets, said it has received CE-mark approval for its Metricath Gemini balloon-catheter product.

The device is used during angioplasty procedures to measure and treat damaged blood vessels in patients suffering from cardiovascular disease. The approval allows the company to market and sell the product in the European Union, where more than 800,000 people undergo angioplasties each year.

TUV Rhineland (Cologne, Germany), MEV's Notified Body, granted CE-mark approval for the Metricath Gemini device for use in both coronary and peripheral vascular applications throughout the EU.

Medical Ventures said it would begin marketing the product through its existing distributors in Italy, Greece, Austria and Switzerland, and is pursuing additional distribution agreements in other European countries.

The Gemini is part of the company's patented Metricath System, consisting of a small electronic console unit and disposable, balloon-tipped catheters. The system allows doctors to measure the internal diameter and area of blood vessels and stents. The Gemini device's high-pressure angioplasty balloon can then be used to enlarge vessels or under-deployed stents by expanding the balloon within the artery.

MEV said the Gemini allows doctors to measure and treat diseased vessels with a single catheter. Current practice requires multiple catheters to perform the two functions, or relies on doctors estimating vessel size and stent expansion using angiography imaging, a technique that often has poor accuracy relative to actual measurement.

“Getting CE-mark approval for this product is great news for our company,“ said Medical Ventures President and CEO Paul Geyer. “It's a cost-effective, easy-to-use technology, and its dual functionality has been shown to offer distinct clinical advantages.“

The Metricath Gemini was previously cleared by the FDA for use in peripheral artery procedures in the U.S. MEV is conducting a clinical trial to support its FDA application to use the device in coronary procedures.

New dermal filler is launched

FzioMed (San Luis Obispo, California) reported the European launch of Laresse Dermal Filler, which is the first ultra-smooth, non-permanent filler created from the company's patented polymer science. Laresse is used for the correction of facial soft-tissue contour deficiencies such as wrinkles and lines caused by sun exposure, aging and other factors.

FzioMed recently reported the establishment of an operating subsidiary in the United Kingdom to lead the sales launch of Laresse in the UK and to expand direct sales of the product throughout Europe later this year.

The first of a line of dermal fillers being developed by the company, Laresse was introduced at last month's Facial Aesthetic Conference and Exhibition in London, and at the British Association of Plastic Surgeons summer meeting being held this week in Sheffield, UK.

The company said the smooth, easy-flowing gel is composed of pure, absorbable medical polymers that have a “long history of safe use in pharmaceutical, medical device and nutritional products.“

Laresse is long-lasting but non-permanent, FzioMed said, and is the first filler without many of the drawbacks of hyaluronic acid and collagen fillers. The product is not manufactured from either bacterial or animal sources and it is not chemically cross-linked.

“All of the hyaluronic acid fillers commonly used today are derived from bacterial fermentation or animal byproducts, and they have to be chemically cross-linked in order to last in the skin,“ said Richard Berg, PhD, vice president of research and chief science officer. “Laresse is not made from HA so it has no bacterial or animal components, no cross-linking chemicals, and no gel particles.“

Plans for a U.S. clinical trial with Laresse are under way.

Privately held FzioMed is developing absorbable biomaterials based on its Oxiplex technology. Oxiplex is an absorbable polymer with uses in a variety of specialties, including orthopedics, spine, gynecology, general surgery and aesthetic surgery.

1st use of Leksell Perfexion system

Elekta (Stockholm, Sweden) said the Leksell Gamma Knife Perfexion, its new system for stereotactic radiosurgery, has been used clinically for the first time. The system, which Elekta said “represents a completely new technological approach,“ was used to treat patients at University Hospital La Timone (Marseille, France).

Leksell Gamma Knife Perfexion is designed for unlimited cranial reach and developed with a strong focus on ease of use and comfort for both patients and staff, the company said. “This quantum leap provides a radiosurgical platform for further refinement and expansion of procedures in the brain, cervical spine and head and neck regions,“ Elekta said in a statement.

University Hospital La Timone is first hospital to have a Leksell Gamma Knife Perfexion installed and in clinical use. Three patients were successfully treated on Monday.

Barcelona office for Lenstec

Lenstec (St. Petersburg, Florida), a provider of lens implants and devices used in cataract and refractive surgery, reported the opening of a new Barcelona sales office, which the company said would help meet growing European demand for its products.

Lenstec Spain expands the company's existing European operations, which include a UK sales and marketing office in Yorkshire, England. The new Barcelona office will serve France, Portugal and the fast-growing Spanish market, which Lenstec said accounts for one of Europe's highest volumes of refractive surgery procedures.

The company said that Josep Manuel Aler has been named to lead the new Barcelona office. He joins Lenstec with more than 15 years of ophthalmic and high-tech industry experience.

“Lenstec Spain will advance our global strategy by enabling us to sell products directly to surgeons in these high-growth regions,“ said Lenstec CEO and Chairman John Clough. “Our goal is to make new technologies such as the Tetraflex accommodating IOL and Softec aberration-controlled cataract lenses readily available across key markets in Europe, Southeast Asia and the Americas.“

Lenstec's Tetraflex accommodating IOL has been available commercially in Europe since 2003. The Softec HD lens is a new aspheric aberration-controlled IOL recently introduced to the European market.