Irvine cardiovascular device maker Edwards Lifesciences Corp. has been busy during the past six months, particularly getting its Edwards Sapien catheter-implanted replacement heart valve up and running in the U.S.
That busy run continued in May as the company held its annual stockholders’ meeting, where it updated audience members on its 2012 progress while reviewing 2011.
Edwards is “fortunate to be enjoying a great deal of growth,” Chief Executive Michael Mussallem said. “We’ve completed quite a few milestones already this year.”
Also at the meeting, the Illinois State Board of Investment submitted a successful resolution to have Edwards’ directors “facilitate a declassification” to force board members to stand for annual re-election.
“Having directors stand for elections annually makes directors more accountable to shareholders and could thereby contribute to improving performance,” said Lisa Berg, a representative of the investment board, which owns 23,517 shares of Edwards’ stock.
Those elected to the eight-member board previously served three-year terms and stood for re-election on a staggered basis.
Among recent milestones, Mussallem mentioned evaluation of Edwards Sapien XT, a new generation less-invasive valve in the U.S.; getting European approval of Edwards Intuity; and approval of the Magna Mitral Ease valve in Japan.
“We’ve got a lot more to come,” Mussallem hinted.
As for longer-term strategic goals: “It’s not that complicated,” the Edwards chief executive said. “We’re focused on structural heart disease and we’re focused on critical care monitoring.”
There are “tremendous unmet needs” in those areas, he added.
Mussallem also suggested that shareholders view examples of Edwards’ devices on hand at the meeting.
“Many of our life-saving technologies are on display around the room,” he said. “Each of the stations are chaired by some just incredible Edwards Lifesciences employees [who’d be] happy to tell you about it.”
Defibrillator Trial
Cameron Health Inc.—a San Clemente-based device maker being bought by Boston Scientific Corp.—made the rounds earlier this month with new trial data for its implantable heart defibrillator, after previously jumping a hurdle with the Food and Drug Administration.
Cameron officials presented results of a study at the Heart Rhythm Society’s annual scientific sessions in Boston showing that its S-ICD implantable cardioverter defibrillator was proven safe and effective in a 330-person clinical trial.
Boston Scientific, of Natick, Mass., agreed to buy Cameron in March in a deal that could be worth up to $1.35 billion, depending on several regulatory milestones.
The company’s device is distinguished by its lack of intravenous electric lead wires to transmit electricity to the heart. Lead wires can often cause serious patient complications.
“We did not observe the typical lead-related complications with the S-ICD (defibrillator), so having an alternative treatment for patients that can virtually eliminate transvenous lead complications is an important step forward for ICD therapy,” Martin Burke, director of the University of Chicago’s Heart Rhythm Center, told Reuters.
An FDA advisory panel said last month that Cameron’s defibrillator’s benefits outweighed its risks. The FDA generally follows its panels’ advice when it comes to medical device approvals.
Griffin-American
Griffin-American Healthcare REIT II Inc., a Newport Beach-based healthcare real estate investor, has bought five medical office buildings for $52.5 million from three separate sellers.
The buildings have a total 223,000 square feet of space.
They are located in Chula Vista, south of San Diego; Tempe, Ariz., and Houston and Amarillo in Texas.
The largest of the acquisitions is Centre Medical Plaza, which is in Chula Vista and has nearly 75,000 square feet between two buildings.
Griffin-American bought the buildings from unidentified third-party sellers. The company, which was previously a unit of Santa Ana-based Grubb & Ellis Co., had a portfolio of 76 healthcare-related buildings valued at some $715 million as of May 1.
Bits and Pieces
Irvine-based drug maker Allergan Inc. said that its flagship Botox drug was recommended by the National Institute for Health and Clinical Excellence in the United Kingdom for preventing chronic migraine headaches in adults.
Allergan said once the agency publishes its final guidance next month, Britain’s National Health Service’s primary care trusts will have 90 days to make funding and resources available.
