Medical Device Daily and MDDs

Amber Master Fund (Cayman Islands) has increased its holding in LVL Medical Group (Lyon France) to 18.68%, making it the single largest shareholder after the company's founder, Jean-Claude Lavorel, who holds 42% of the capital but exercises 54.6% of the voting rights.

Specializing in home-based medical assistance services, LVL saw its share price jump 130% over the past year as it tamed profitability problems due to a too-rapid expansion into Germany in 2003.

In July, the company reported a further expansion in Germany with two more acquisitions reinforcing its foothold in the populous northern state of Schleswig-Holstein. LVL draws 22% of its annual revenue in Germany, while France, where the company is ranked third in market share, accounts for the majority of sales.

LVL installs equipment for prescribed home care and provides patient and caregiver training and medical device maintenance. The company operates in three care areas — respiratory assistance and treatment of chronic respiratory insufficiency; perfusion, nutrition and insulin therapy services, including chemotherapy, antibiotic therapy, pain management or chronic digestive illnesses; and home support furnishing such as beds, lifts and wheelchairs.

Hedge fund Amber Master Fund invested in a French debt instrument for LVL in 2004 called OCEANE (option de conversion et /ou d'Échange en actions nouvelles ou existantes) where, with the termination of the three-year loan, it could either receive a cash reimbursement of 141 for each debt instrument, or trade each OCEANE share for 4.18 actions of LVL, an exchange rate reported in August.

Though LVL reported a steady 16% increase in sales to 146 million ($65 million) and exceeded projections with a 37% gain in net income, the Paris stock exchange pushed the share price down 2% to 122 ($31) and it has surfed just below that value since.

Lavorel said in a July interview with analysts that the expansion in Germany has been marked by costly closings and consolidations of acquired care facilities but that the market promises revenue growth almost four times greater than projected over the near term in the French market, which he said is far more rigid for home care reimbursement from the state health insurance fund.

Yet Germany is the limit to the horizon for expanding, "for the next year or so," he said. "For the moment, the strategy is not to expand into other European countries but to develop France and Germany."

LeMaitre switches to direct sales in Italy

LeMaitre Vascular (Burlington, Massachusetts), a provider of peripheral vascular devices and implants, has reached an agreement to launch a direct sales force in Italy in January 2008.

The company currently sells its products in Italy through an exclusive agreement with Serom Medical Technologies, but LeMaitre and Serom have agreed to terminate Serom's exclusive rights on Jan. 25, 2008, in exchange for the payment of an undisclosed sum. Serom has held exclusive distribution rights in Italy since 1992.

LeMaitre said its products sold to Serom in 2006 totaled about 1900,000, more than any other distributor for the company. LeMaitre said it believes that Serom's hospital-level sales were about 11.9 million during that same period.

The U.S. firm said it expects to open an office in Rome in 4Q07 and commence direct sales to Italian hospitals in 1Q08.

LeMaitre said it has hired a general manager for its Italian operations to manage a smooth market transition and said that Serom will provide a range of consulting services designed to facilitate the transition.

"Selling direct in Italy allows us to develop closer relationships with our vascular surgeon customers and also allows us to capture higher gross margins," said Peter Gebauer, president of LeMaitre's international operations. "Italy is at the forefront of the endovascular revolution and is the largest aortic stent graft market in Europe. We look forward to having a direct sales presence in this market."

George LeMaitre, CEO and chairman of the company, said the move is "The continued execution of the 'Go-Direct' strategy that we initiated in 1998 in Germany, and that we have continued in the UK, Japan, the Benelux, Austria, Sweden, and this year France."

Ballester named CEO of Sorin Group

AndrÉ-Michel Ballester, president of the Cardiac Rhythm Management unit of the Sorin Group (Milan, Italy) since 2004, has been named CEO and a board member of the parent company.

Sorin Group is the largest European cardiovascular company and a leader in technologies for cardiac surgery.

Ballester was, from 2000 to 2004, corporate VP EMEA, Asia and Latin America, for Edwards Lifesciences (Irnine, California). For more than 10 years prior to Edwards' spin-off from Baxter International (Deerfield, Illinois), Ballester held several executive positions in Europe and the U.S. for that firm and was named president of the CardioVascular Group, Europe, in 1997.

"Our new CEO is the originator of the strong growth shown by our Cardiac Rhythm Management business unit," said Sorin Group Chairman Umberto Rosa. "This internal choice recognizes unquestionable success. AndrÉ-Michel will first focus on finalization of Sorin Group's new strategic plan, and actively start its implementation."

"I am proud to become CEO of a great company with considerable pedigree, very innovative products and an outstanding team of people, helping treat more than 1 million patients per year around the world" said Ballester.

Sorin Group has around 4,500 employees and about 5,000 public and private treatment centers in more than 80 countries.