Medical Device Daily

Cosmesis — meaning, in general, looking good — and cardiology are both strong growth areas for the medical device industry. And both are driven by essentially the same demographics: aging populations that want to look better and feel better.

Recent end-of-year reports looked at key trends in these two arenas: The American Society for Aesthetic Plastic Surgery (ASAPS; New York), predicting developments for the new year, and the American Heart Association (AHA; Dallas), picking the most important developments for cardiology during 2004.

Among the main cosmetic surgery trends for 2005, according to the ASAPS — based, it said, on interviews with leading plastic surgeons around the country — are:

• 2005 will bring a new generation of breast implant fillers and coatings; advanced lasers that rejuvenate the skin from the inside out; new products for scar management and prevention of keloids; and permanent injectable treatments for facial lines and wrinkles may be the biggest “buzz“ in cosmetic plastic surgery.

• Arthroscopic facial rejuvenation procedures may become more popular. Suture suspension techniques, promising facial rejuvenation with minimal downtime, may also increase in popularity. “However, many patients will opt for traditional facelifts or endoscopic procedures with more predictable and long-lasting results,“ according to the ASAPS.

• Experimental techniques for non-invasive fat removal, as a future alternative to liposuction surgery — or lipoplasty — will be tested in clinical trials.

• Hyaluronic acid (Restylane, Hylaform) will surpass collagen as the most popular soft tissue filler for lines and wrinkles. Additional hyaluronic acid products developed specifically for facial volume enhancement and improvement of depressed scars will be introduced.

• A growing number of women will opt for smaller-size breast implants.

• The number of patients seeking plastic surgery for body contouring after dramatic weight loss will rise by at least 20% in 2005, reflecting growing awareness of the long-term health benefits of weight loss for the morbidly obese.

• Cosmetic surgery for racial and ethnic minorities in the U.S. will increase, most likely exceeding 20% of the total procedures performed.

• More plastic surgeons will offer lifestyle assessment and counseling to their cosmetic surgery patients, with a focus on “wellness basics.“

• National attention to issues of patient safety will result, in some states, in more stringent requirements for physician credentials to perform cosmetic surgery. The ASAPS said it will be among the leaders of this movement in 2005.

And among the AHA's 2004 device-related milestones — from a “top 10“ list by association president, Alice Jacobs, MD — were:

• FDA approval of the first implantable artificial heart — the CardioWest Total Artificial Heart from Syncardia Systems (Tucson, Arizona) (Medical Device Daily, March 19, 2004) — for bridge to transplant. A descendant of the Jarvik-7, first implanted in 1982, the CardioWest device takes over a patient's failing ventricles, the heart's lower two pumping chambers and all cardiac valves. The heart is for those no longer responding to other treatments and at risk of imminent death from non-reversible bi-ventricular failure.

• Tissue plasminogen activator (tPA), by itself, effectively dissolves clots that can cause an acute ischemic stroke. But using ultrasonography via continuous transcranial Doppler, in combination with tPA improves the drug's clot-busting abilities, a study showed.

• Use of a filter collects fatty blockages in arteries leading to the brain that can cause stroke or heart attack. Researchers studied 334 patients with clogged carotid arteries. About half had an operation — called carotid endarterectomy — to widen blocked neck arteries; the others underwent the refined angioplasty technique. One year later, the rates of death, heart attack and stroke were significantly lower in those undergoing the new procedure. Guidant (Indianapolis) was the first U.S. firm to win FDA approval for this technology, its Rx Acculink carotid stent and Rx Accunet embolic protection system (MDD, Sept. 2, 2004).

• Defibrillators placed in shopping malls, sports venues and other public places — and used by trained volunteers — can double the survival rate of cardiac arrest victims. In a study, defibrillators were placed in key locales at nearly 1,000 shopping centers, recreation centers, apartment and entertainment complexes and community centers in 24 cities across the U.S. and Canada. Over next two years, the volunteers attempted to resuscitate 235 cardiac arrest victims. Those treated by the volunteers who used defibrillators plus cardiopulmonary resuscitation were twice as likely to survive to hospital discharge (29 of 107), compared with those who were treated by volunteers who did CPR alone (15 of 128).

• Researchers reported the creation of long-lasting, functional blood vessels by implanting two types of cells (endothelial cells that line the inner walls of the blood vessels and cells from the outer layer of the blood vessels), into a collagen gel and then implanting them into mice. The blood vessels created by this technique had greater stability and formed long, branching tubes that connected with the mice's own blood vessels. As they matured, they began carrying blood.

In the diagnostics sector, researchers uncovered three new mutations in MEF2A, the same gene they directly linked to heart attacks in 2003. The MEF2A gene plays a role in protecting artery walls from building up plaque that can impede blood flow and lead to heart attacks. The study detected the three mutations in four of 207 people with coronary artery disease. In contrast, it wasn't found in any of 191 people with no signs of heart disease. The results suggest that nearly 2% of those with coronary artery disease — the equivalent of hundreds of thousands of Americans — may carry a MEF2A mutation.

In the near future, genetic testing for MEF2A mutations may help to pinpoint patients at increased risk of coronary artery disease before symptoms develop.

In other breakthrough developments, the AHA noted research built on previous findings that the human heart can generate new muscle cells. Scientists took that insight a step further, reporting at the 2004 AHA Scientific Sessions that the heart contains stem cells that can generate muscle cells and other cells — and that these cardiac stem cells can regenerate heart tissue after a heart attack. Theoretically, the laboratory-grown stem cells can be returned to the same patient to stimulate the growth of new heart muscle and repair the injured heart, opening therapeutic opportunities for treating heart failure.

The 2,200-member ASAPS bills itself as “the only plastic surgery organization devoted entirely to the advancement of cosmetic surgery.“

The primary mission of the AHA is “to reduce disability and death from cardiovascular diseases and stroke.“