Medical Device Dailys

PARIS — Carestream Health (Rochester, New York) chose the French Radiology Congress to roll out the world premiere for DRX Evolution a fully automated digital radiology (DR) room

Carestream has not been secretive about this latest upgrade for its DR suite, having announced the system in July in Germany.

In August the company received 510k clearance from the U.S. Food and Drug Administration (FDA) and began taking pre-launch orders, saying it would begin shipping in late 2009.

DRX Evolution is a room built around the company's best-selling DRX1 a wireless, removable detector panel that allows conventional computer radiology operations to convert over to digital technology by simply replacing the computer radiology (CR) phosphorous plate cassette.

Instead of pulling the CR cassette to place it in a reader, the DRX1 instantly sends the acquired image to the radiology workstation, enhancing productivity and patient through-put.

The manager for the new product line, David Chan said DRX Evolution is the final step on what he described as a path Carestream creates for upgrading to DR capabilities.

"In a first step a radiology department can buy the portable detector simply replacing the CR cassette they have been using as DRX1 works with any existing CR projector, which explains it popularity with radiologists," he said.

"In a second step, they may choose to replace their existing equipment with a modular system giving configurations for wall mounted detectors or angled patient positions," he said, adding the radiology group can change at their own pace and preference for juggling cost against needed capabilities.

"The DRX Evolution is a final step that adds the advantages of automating workflow and ergonomics that improve productivity," he said.

The motorized projector arm for the Evolution suite features auto-tracking and auto-positioning functions, as well as one-hand manual projector adjustment.

An unexpected feature is an anti-collision detector to prevent the projector from bumping into a radiologist or patient suddenly moving across its path as it auto-tracks or auto-positions itself.

Norman Yung, Chief Marketing Officer with Carestream's Digital Medical Solutions group said DRX Evolution enters a global market in full transition from computed to digital radiology.

"We could say the conversion began around 2002 and that if the worldwide market for radiology stands at $3.8 billion today, CR continues to hold about $2.1 billion, showing that DR has gained a 45% share," he said.

The conversion is moving more quickly in the United States, Carestream is now targeting a more aggressive effort in Europe.

Synovis ges CE mark for Veritas

Synovis Life Technologies (St. Paul, Minnesota), a biomaterial and surgical products company, has received CE mark approval for its Veritas Collagen Matrix, allowing the company to sell Veritas in the European hernia repair and breast reconstruction markets. Veritas is a biomaterial which acts as a scaffold that allows for rapid repopulation and revascularization by the surrounding host tissue.

"CE mark approval for these indications is a significant milestone for Veritas. With the addition of the European market for hernia repair and breast reconstruction, we look forward to expanding our presence in the worldwide soft tissue repair market and increasing our international revenue," said Richard Kramp, president/CEO of the company. "We have already trained our independent distributors in Europe on the advantages of Veritas, and they will immediately start to sell Veritas to the European physician community. The hernia repair and breast reconstruction applications represent large and strong European market opportunities for Synovis."

Veritas is an exceptionally supple and durable product. In addition to providing strength and flexibility, Veritas avoids acute and chronic infections and unwanted chronic inflammation that occurs frequently in response to the use of synthetic patches. The distinct characteristics of Veritas, which include its pericardial substrate and proprietary processing, offer functional and ease of use advantages over other biological patches.

Synovis launched Veritas into the ventral hernia market in the U.S. in early 2007 and in the breast reconstruction market in 2008.

Cohera receives approval for TissuGlu trials

Cohera Medical (Pittsburgh) reported that it has received approval to begin human clinical trials of its lead product TissuGlu in Germany. Receipt of the approval allows Cohera to proceed with patient recruitment and initiation of an investigational study of the company's novel internal surgical adhesive being developed for its first intended use to adhere surgical tissues together in large flap surgeries.

The feasibility study will investigate the safety and preliminary effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries. The study will be conducted at three sites near Bonn, Frankfurt, and Freiburg in Germany and will enroll 40 patients. Patient recruitment is expected to begin in November this year.

Currently, patients who undergo abdominoplasty require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and excessive fluid accumulation often requires an additional procedure to remove it. TissuGlu is designed to adhere the tissue flaps created during the procedure, thereby reducing fluid accumulation and ultimately reduce or eliminate the need for surgical drains and reduce the risk of related complications.

"This trial will be our first study of TissuGlu in patients and the trial's approval validates the biocompatibility and pre-clinical profile of TissuGlu," said Chad Coberly, VP of clinical, regulatory and legal affairs of Cohera. "Initiation of this study will allow the company to move closer to a regulatory approval application in Europe for the CE mark and application for a larger U.S. based trial."