Edwards Lifesciences Corp. recently put a human face on its business with a patient’s presentation at an industry conference.
“Our work really benefits patients,” said Michael Mussallem, chief executive of the Irvine-based cardiovascular device maker. “It’s very powerful stuff [and] the ultimate winner [is] the patient.”
Mussallem spoke at a medical device and investor forum—presented by Aliso Viejo technology booster group Octane—then brought up Connie Alexander, former professional roller skater who received an Edwards Sapien heart valve implant at Cedars-Sinai Medical Center in Los Angeles.
Alexander talked about her health history, including a double mastectomy and an operation to have four ribs removed after cobalt treatments for her cancer caused deterioration. She later started to have symptoms of severe aortic stenosis, which limited her daily activities, and learned she needed valve-replacement surgery.
She recalled that she received the valve on a Thursday, two days after her standing hair appointment,” Alexander recalled. “Saturday, I went home.
“Tuesday, I went and had my hair done again–never missed a hair appointment,” she added to the amusement of the audience.
At 79, Alexander said she was a “baby” compared to the average 83-year-old in Edwards Sapien clinical trials.
Mussallem described Sapien’s clinical and regulatory path to market with Sapien. “We had an awful lot of back and forth with the FDA,” he said.
Other panels during the forum include one discussing the 2012 presidential election and what it could mean to medical technology. A keynote speech focused on ophthalmology, and another session looked at exit strategies for medical-device makers.
Erik Paulsen, a Republican congressman from Minnesota who co-chairs the Congressional MedTech Caucus, spoke about attempts to repeal a medical device tax that’s scheduled to start in January.
Paulsen is the main sponsor of the proposed Defend Medical Innovation Act. His district is in the Twin Cities, which is home to a number of device makers.
Several area Republicans in the House signed on as co-sponsors of the bill. Those include John Campbell, who represents Irvine and parts of Newport Beach and South County, and Edward Royce, who represents part of North Orange County.
Paulsen originally introduced the bill in 2010 and brought it back in January 2011. It passed the GOP-controlled House in June and is now in the Senate.
A 2.3% tax on medical device makers’ revenue is designed to raise more than $20 billion across a 10-year period to pay for federal healthcare reform.
Sovereign Expansion
Mission Viejo-based Sovereign Healthcare said its joint venture partner, Scottsdale Healthcare, has acquired majority ownership of Biltmore Surgical Center in Phoenix on undisclosed terms.
Sovereign operates ambulatory surgery surgeries in the southwest, with a concentration in Southern California and Arizona. The company works with doctors, hospitals and health systems and provides management and strategic leadership.
The company provides management services for Newport Irvine Surgical Specialists, which is made up of several local surgeons with independent private practices in Irvine, Aliso Viejo, Newport Beach and Tustin.
The Sovereign and Scottsdale Healthcare joint venture now has three majority-owned outpatient surgery centers in metropolitan Phoenix. The other two are North Valley Surgery Center in Scottsdale and Paramount Surgery Center of Mesa in Mesa.
Biltmore Surgical Center opened in late 2010.
Bits and Pieces
Irvine-based patient monitor maker Masimo Corp. started a limited market release of its Universal ReSposable Pulse Oximetry Sensor system. Masimo said the new sensor was created after more than a decade of research and development that included clinician feedback. … NeurOptics Inc., an Irvine-based medical device maker, said a study showed its pupillometers reliably measured the presence and quality of the pupillary light reflex after heart attacks. NeurOptics’ devices are used in critical care and emergency medicine, as well as for ophthalmic surgery and research. … French drug maker Ipsen SA said it’s no longer obligated to pay $12.5 million in exchange for equity in Inspiration Biopharmaceuticals Inc., a hemophilia drug maker that moved from Laguna Hills to Cambridge, Mass., last year because Inspiration “had not raised third-party financing” by Sept. 30.
