A Medical Device Daily

SyntheMed (Iselin, New Jersey), a biomaterials company developing anti-adhesion and drug delivery products, reported that Repel-CV, the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received CE-mark approval in the European Union.

Repel-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of the surgical procedure to reduce the extent and severity of adhesions forming between the surface of the heart and the inner surface of the sternum. After a period of about four weeks, Repel-CV is reabsorbed through exposure to moisture and body temperature.

The CE-mark approval enables the company to begin marketing the product for use in all cardiothoracic surgical procedures. Adhesions, or scar tissue, occur in virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing both the length/cost of the surgical procedure and the risk to the patient.

SyntheMed said there are an estimated 350,000 open-heart surgeries conducted annually in the EU, with about 15% identified as secondary procedures.

Robert Hickey, president/CEO, said, “Surgical adhesions represent a significant concern for patients who undergo secondary open-heart surgery, resulting in heightened risk of mortality and other complications, longer surgical procedures and additional medical costs.”

He said the company has established a network of independent distributors to “rapidly commercialize Repel-CV in the EU and [we] look forward to bringing the demonstrated benefits of this product to both patients and physicians.”

Hickey noted that in addition to the CE-mark approval, SyntheMed expects to soon announce the results of the U.S. pivotal clinical trial for Repel-CV. “This trial, if positive, could result in Repel-CV becoming the first adhesion barrier approved by both the FDA and European Union regulatory authorities for use in cardiac surgery.”

Contour Threads okayed for expanded uses

Angiotech Pharmaceuticals (Vancouver, British Columbia) said it has received CE-mark approval to expand the use for its Contour Threads product line, encompassing aesthetic as well as plastic and reconstructive surgical procedures.

Having already been approved for use in brow, neck and mid-face lift procedures, Angiotech is currently marketing the product for facial procedures through distribution agreements in the European Union. Angiotech now also can market the product line in Europe for breast lift and nipple repositioning procedures.

The Contour Threads technology enables surgical sutures to self-anchor and suspend sagging tissue without the need for suture knots. Angiotech said it plans to develop other potential indications of the Contour Threads product line for minimally invasive aesthetic procedures, such as breast lifts and other body-contouring indications.

“The Contour Threads product is a key part of [our] aesthetic franchise, and we believe that Europe is going to be a great area of opportunity for this business,” said Dr. William Hunter, president/CEO. “With this market expected to grow over the next five years due to more favorable attitudes toward aesthetic enhancement and augmentation in Europe, we believe we will see strong momentum for minimally invasive procedures like those using Contour Threads products.”

Market studies have indicated the global market for aesthetics procedures generated more than $15 billion in 2004. Angiotech said it believes that facelift-type procedures performed with Contour Threads products could increase the aesthetic procedure market by offering a cost-effective, minimally invasive alternative to the traditional facelift procedure.

The company said doctors and patients alike are interested in the procedure, which can be performed in a physician's office with no general anesthesia and very little “down time” for patients. Angiotech also is working with plastic surgeons to explore the use of the Contour Threads product line in traditional facelifts.

Angiotech said it anticipates that the same technology used in the Contour Threads product will be adapted for general wound closure in orthopedic, cosmetic, vascular and endoscopic surgery. Eliminating knot-tying saves time, minimizes the risk of infection and reduces wound leakage, the company said.

Kerkhof named CEO of Chiltern

Chiltern International (London), an independent clinical contract research organization, has named Glenn Kerkhof CEO. Kerkhof has more than 13 years of management experience in the pharmaceutical services industry.

He joins Chiltern from Charles River Laboratories, where he served as the vice president of global operations for clinical services and was responsible for operating a business unit comprised of more than 1,100 people in 20 countries. Prior to Charles River, Kerkhof served at Inveresk Research Group as vice president of operations for clinical services in Europe and Asia-Pacific.

Kerkhof's appointment follows the recent acquisition of Chiltern International by Czura Thornton , a private investment group led by Antony Czura and Nick Thornton. Chiltern employs more than 850 worldwide, with locations in the UK, France, Germany, Italy, Spain, Poland, the Czech Republic, Ukraine, India, South Africa and across the U.S.

Abiomed to present at ISRBP meeting

Abiomed (Danvers, Massachusetts) reported a lengthy schedule of presentations at the 14th Congress for the International Society of Rotary Blood Pumps (ISRBP) in Leuven, Belgium, set for Aug. 31-Sept. 2. Representatives will make presentations on Abiomed's heart recovery technology, including the Impella Recover 2.5 and Impella Recover 5.0. Abiomed makes products designed to assist or replace the pumping function of the failing heart.