Santa Ana-based Abbott Medical Optics continues to forge ahead with new products.
The maker of eye devices, a unit of Chicago-based Abbott Laboratories, recently introduced two versions of its Tecnis Multifocal intraocular lenses.
Intraocular lenses are placed in a patient’s eye to restore vision after a cataract or a clouding of the eye’s natural lens.
Tecnis Multifocal is designed to provide quality vision at multiple distances, as opposed to traditional monofocal intraocular lenses, which are designed to restore far or distance vision.
“Restoring or improving sight can make a huge impact on how people live their lives, which is why Abbott is continually investing in the research and development of advanced treatments to help people see their very best,” said Murthy Simhambhatla, an Abbott senior vice president who oversees the medical optics business.
Abbott Medical mentioned that the Tecnis Multifocal intraocular lenses were well-studied and that the Food and Drug Administration’s approval was based on a 445-patient study.
The study showed, among other things, that more than 80% of participants reported being able to function comfortably without eyeglasses at all distances, and that 93% reported they would have the same intraocular lens implanted again.
Abbott Medical, which came about after Abbott bought Advanced Medical Optics Inc. for $2.8 billion in 2009, has in recent years focused on organic growth and research and development. The company has said it can focus internally because of its parent, which has annual sales of $20.2 billion and a recent market value of about $70 billion.
Dallen Medical Device Cleared
San Clemente-based Dallen Medical Inc. received clearance from the Food and Drug Administration for its new Tensyn Plug.
Dallen bills it as the first adjustable orthopedic fixation device. It’s a successor to the Tensyn Band and is cleared for uses such as wrist and hand repair and joint stabilization. It has knotless banding technology that allows stable fastening of soft tissue in the extremities while allowing natural movement of the joints not available with rigid screw fastening.
Chief Executive David Mills said in a statement that Dallen will make another FDA submission for use of the Tensyn Plug in knee and hip procedures.
Heart Device Introduced
UC Irvine Health, which operates the 412-bed UC Irvine Medical Center in Orange and other clinical, medical education, and research enterprises, introduced a remote heart-failure monitoring device that allows its cardiologists to measure patients’ pulmonary artery pressure and heart rate measurements.
CardioMEMS is made by St. Paul, Minn.-based St. Jude Medical Inc., which employs 352 in Orange County. UC Irvine Health said it’s about the size of a dime and is implanted in the patient’s pulmonary artery during a right-heart catheterization procedure. It said it doesn’t interfere with other devices, such as a pacemaker or defibrillator.
The device received FDA approval last May.
Sequent Medical Gets Trial OK
Aliso Viejo-based medical device maker Sequent Medical Inc. received the FDA’s green light to proceed with a clinical trial of its “Web” aneurysm embolization device.
It said it will test the device in 150 patients who have either ruptured or unruptured wide-neck intracranial bifurcation aneurysms. The company added that researchers will work at 25 investigational sites, 20 of which are in the U.S.
The company said that Web, which has European regulatory clearance, has treated 1,300 ruptured and unruptured aneurysms in patients in Europe, Latin America, Australia and New Zealand.
Bits & Pieces
Milan Panić, chief executive and founder of MP Biomedicals LLC in Santa Ana and founder of ICN Pharmaceuticals Inc. (now Canada-based Valeant Pharmaceuticals International Inc.), received an award from the New York-based Lifeline Humanitarian Organization last month. Panić, a former prime minster of Yugoslavia, received the award for his “visionary work to bring peace to conflict-ridden Serbia in the early ‘90s and for his efforts to develop ribavirin, a drug used to treat tens of millions of people worldwide,” according to a note from the organization. … Aliso Viejo-based skilled nursing operator Covenant Care California LLC picked Troy, Mich.-based CareTech Solutions Inc. to provide cloud-based software hosting and services for its information technology infrastructure and processes.
