Edwards Lifesciences Corp. recently hit another milestone with one of its less-invasive heart valves.
The Irvine-based cardiovascular device maker said this month that three implants of its Fortis mitral transcatheter heart valve were performed by the heart team at St. Thomas Hospital in London.
Fortis, which isn’t commercially available in any country, features what Edwards called its “most advanced, treated bovine pericardial tissues.”
“These first patients had severe mitral valve disease and many risk factors that prevented them from undergoing surgery,” Dr. Vinayak Bapat, a consultant cardiothoracic surgeon for St. Thomas, said in a news release. “After careful evaluation and close consultation with the patients and their families, we determined that this therapy could potentially extend and improve their lives.”
Bapat added that the hospital is “very pleased with the initial recoveries” of the trio of patients.
Edwards noted that other St. Thomas Hospital heart team leaders, including Drs. Martyn Thomas and Jane Hancock, had experience with less-invasive heart valve procedures, including transcatheter aortic valve replacement.
Edwards’ range of Edwards Sapien replacement heart valves are used in transcatheter aortic valve replacement procedures.
Regarding the Fortis implants, Edwards Chief Executive Michael Mussallem said “mitral valve disease is undertreated worldwide, and there is a particular need among patients who are too high-risk to benefit from traditional surgical options.”
He continued: “This early experience provides a very important opportunity for learning in this challenging anatomy. Although durable success will not be known without significantly more experience and longer-term follow up, we are excited about this potential opportunity that we believe may be very meaningful for patients.”
Peregrine Gets Boost
Tustin-based Peregrine Pharmaceuticals Inc.’s stock shot up this month after it said it would present data from three preclinical studies at Keystone Symposia sessions in Canada.
The company is working on several cancer drug candidates, including its lead compound, bavituximab.
Peregrine shares closed up 42% on March 5, a day after the company issued a news release when the market closed. Its stock is up 60%, with a recent market value of $393 million since the start of the year.
The studies highlight the immuno-oncology and antiviral potential of the company’s PS-targeting antibodies, according to Peregrine.
Drs. Bruce Freimark, Peregrine’s director of preclinical research oncology, and Cyril Empig, its associate director of preclinical research, infectious diseases, presented two of the studies. Dr. Xianming Huang, an assistant professor at the University of Texas Southwestern Medical Center in Dallas, presented the other study.
OrthAlign Signs French Deal
Aliso Viejo-based OrthAlign Inc. said this month that it signed a distribution agreement with Gémenos, France-based Lima France. OrthAlign makes devices that help orthopedic surgeons navigate procedures in order to precisely position implants.
Lima France, a unit of Italy-based Limacorporate SPA, will distribute OrthAlign’s KneeAlign devices. The company said in a news release that about 45,000 total knee arthoplastic surgeries are performed in France annually, with a 10% annual growth rate.
KneeAlign “effectively differentiates our product offering in the French marketplace and addresses those immediate needs of our surgeons,” said Thierry Casat, Lima France’s general manager.
OrthAlign signed a distribution pact last month with Biomet Japan, a unit of Warsaw, Ind.-based Biomet Corp., to distribute KneeAlign in that country. Japanese regulators cleared KneeAlign late last year for use in total knee arthoplasties.
Bits and Pieces
Irvine-based Nihon Kohden America said it received a patent from the U.S. Patent and Trademark Office covering what it called “a unique smoothing algorithm” that reduces false alarms in patient monitors. Nihon Kohden America is a unit of Japan-based Nihon Kohden Co. … Eden Prairie, Minn.-based DDL Inc. said it expanded medical device testing capacity at its DDL West laboratory in Fountain Valley. DDL provides package, product and materials testing services. … Garden Grove Hospital Medical Center, La Palma Intercommunity Hospital and West Anaheim Medical Center were recognized in a “100 top hospitals” ranking by Truven Health Analytics, formerly Thomson Reuters. The three hospitals are owned by Ontario-based Prime Healthcare Services. … Thomas Burns, chief executive of Laguna Hills-based Glaukos Corp., and Jennifer Simpson, a professor at UC Irvine Health’s Gavin Herbert Eye Institute, were recently honored by the Columbia, Md.-based Foundation Fighting Blindness at a fund-raiser. The event was at the Island Hotel in Newport Beach and was chaired by William Link, a managing partner in the Newport Beach office of venture capital firm Versant Ventures; James Mazzo, chief executive of Irvine-based AcuFocus Inc.; and Dr. Roger Steinert, the Herbert Institute’s director.
