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French orthopedic implant maker Dedienne Santé (Mauguio) has attracted €6.2 million ($9.1 million) in new financing to accelerate its entry into new markets for hip and knee replacements.

Turenne Capital (Paris) invested almost half of the new funding as it grew its majority share in a leveraged buy-out of the privately held Dedienne. Banques Populaires Rives de Paris joined Turenne in the financing round, along with a second bank, not named.

Turenne now holds “more than two-thirds” of Dedienne, according to Marc Meneau with the investment fund.

Turenne in the past year has increased its investments in another French orthopedic maker, Aston Medical (Saint-Etienne), and recently traded up its investment in Scient’x (Guyancourt) for a stake in the company’s majority shareholder, Ideal Medical Products (Paris).

Meneau told Medical Device Daily, “Clearly we are looking at opportunities in export of French medical implants,” adding that the near-term focus is on developing markets in Asia, South America and the U.S.

Asia is the primary focus, he said, encouraged by orders from China for Dedienne’s flagship products: IDA, a cemented prosthetic hip, and Tri CCC, a total knee prosthesis with mobile bearing.

Meneau said negotiations for entry to Brazil are in process, and he expects Dedienne to be present in the market through a distribution agreement not later than 2009.

Dedienne, located outside Montpellier, is a subcontract manufacturer for implants already being sold in the U.S., he said, and the company expects to launch its own branded products by 2010, once regulatory approvals are granted.

Dedienne has sustained sales growth of 12% for the past few years, according to Turenne, outperforming the market.

With revenues of just under €7 million ($10.3 million) Dedienne sells only a third of its branded products outside of France but including subcontracted manufacturing for original equipment manufacturers pushes the revenue attributed to exports to almost 50%.

“Exports to this point have largely been a matter of exploiting opportunities as they arose,” said Ludovic Toledo, head of sales for Dedienne.

Dedienne introduced its line of products for hip and knee replacements, as well as the support kits and equipment for the procedures, in the mid-1990s.

With 30 patents, Dedienne holds strong intellectual property, according to Patrick Rondot, company president, adding that new products are being developed to meet a market in continual evolution.

Turenne Capital is a €300 million ($441 million) investment fund with an affiliate Turenne Investment that specializes in privately held French small and medium-sized manufacturers.

CE mark for Tryton’s Side-Branch Stent

Tryton Medical (Newton, Massachusetts), a developer of stents designed for the treatment of bifurcation lesions, said it has received the CE mark for its Side-Branch Stent.

The Side-Branch product is a cobalt-chromium, balloon-expandable coronary stent developed, the company said, “for the treatment of the entire spectrum of coronary artery bifurcation disease.” Tryton said about 540,000 procedures are performed annually to address bifurcation lesions, accounting for 20% of all coronary lesions treated. It said that “no other dedicated solution exists today that fully addresses these lesions.”

Results of the Tryton 1 (First-In-Man) Study were presented by Patrick Serruys, MD, of the Thoraxcenter at Erasmus University Medical Center (Rotterdam, the Netherlands) and Ralf M ller, MD, of Helios Heart Center (Siegburg, Germany).

When the Tryton cobalt chromium bare-metal stent was used with a standard drug-eluting stent (Cypher Select, Taxus or Xience V), no side branch restenosis was observed in the 30 patients treated.

“This technology has the capacity to redefine the treatment of bifurcation lesions and resolve a frequent dilemma of the interventional cardiologist,” said Serruys.

H. Richard Davis, chief technology officer of Tryton Medical, said a market launch of the stent is planned for May in conjunction with the EuroPCR meeting in Barcelona.

Components from St. Jude unit OK’d

St. Jude Medical (St. Paul, Minnesota) said it has received CE-mark approval of two integrated components — the Cool Point Irrigation Pump and the IBI-1500T11 Cardiac Ablation Generator. Designed, the company said the products were designed “to enhance physicians’ ability to perform successful cardiac ablations, [and] were developed for use together with the St. Jude Medical family of Therapy Cool Path irrigated catheters.”

“The pump has been designed for easy set-up and seamless operation with our cardiac ablation generator and for compatibility with our Therapy Cool Path open-irrigated catheters,” said Peter Chen, president of Irvine Biomedical (Irvine, California), a St. Jude company. “Open-irrigated catheters have been proven to effectively create deeper and larger lesions while using less energy than standard therapy catheters.”

In addition to simplicity in set-up and operation, the Cool Point Irrigation Pump provides what St. Jude termed “important control, monitoring and safety features. It enables physicians to program the flow rate they determine to be optimal – up to 40 milliliters per minute – and to monitor the total volume of irrigation solution delivered through an easy-to-read display.”

The pump’s tubing includes an in-line occlusion detector that monitors flow pressure between pump head and catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate – an indication that irrigation ports on the catheter tip may be blocked. The pump also has redundant bubble detectors, each able to detect bubbles as small as two microliters.

The new generator is designed for ease of use with the Cool Point Irrigation Pump. It is programmed for fully automated communication with the pump.

The integrated pump and generator accommodate the Therapy Cool Path family of open-irrigated catheters, which are designed to maintain lower tip-to-tissue temperatures, thereby creating wider and deeper lesions.

St. Jude also noted that the Cool Path family was recently expanded with the CE-mark approval of the Cool Path Duo irrigated ablation catheter, designed for uniform cooling of the entire length of the tip electrode.