One of the most important devices emerging in the 20th century in the cardiovascular sector was the pacemaker. And last month St. Jude Medical (St. Paul, Minnesota) paid tribute to Arne H. W. Larsson, who died Dec. 28 at the age of 86 and was the first person to receive an implantable cardiac pacemaker more than 40 years ago. Larsson was implanted with the pacing device on Oct. 8, 1958, after being diagnosed with a heart block condition known as Stokes-Adams syndrome. The device was developed and manufactured by a Swedish company now part of St. Jude.

At the urging of Larsson's wife, Else-Marie, cardiac surgeon Dr. Ake Senning and medical device engineer Dr. Rune Elmqvist completed the first implantable pacemaker, and Larsson subsequently received 25 more pacemakers. He became an unofficial ambassador for the pacing industry, appearing at many scientific meetings to testify to the technology's value. That initial pacemaker – containing just two transistors and about the size of a hockey puck – was very crude compared to the devices now prescribed for implant in more than 500,000 patients every year. Current devices incorporate aerospace and computer technology and feature advanced circuitry and sensor capabilities. While containing up to 500,000 transistors, they can be as small as a half-dollar.

Commenting on Larsson's passing, St. Jude Medical CEO Terry Shepherd, said, "While we mourn the death of Arne Larsson, we also remember the 43 years of extended life Arne received from medical technology. The story of the first implantable pacemaker is one of courage, creativity and persistence by Drs. Elmqvist and Senning and Arne and Else-Marie Larsson." He noted that the implantation involved great risks, "but Arne's life was saved, and an industry that now provides life-enhancing technology to millions of people around the world began on that day."

Shepherd added: "In 1957, St. Jude Medical's former medical director, the late Dr. C. Walton Lillehei, 'the father of open heart surgery,' collaborated with the co-founder of Medtronic, Earl Bakken, on the first wearable, transistorized pacemaker which was successfully used to treat heart block after some of the earliest open heart surgery cases at the University of Minnesota. These collaborations in Minnesota and Sweden of engineers and physicians were early building blocks of the global medical technology industry." Shepherd added that the result has been to help build three medical technology companies – Medtronic (Minneapolis, Minnesota), St. Jude and Guidant (Indianapolis, Indiana), with headquarters or pacing operations in Minnesota – and that those companies supply more than 95% of the world's pacemakers. St. Jude Medical also maintains a pacemaker research and manufacturing operation in Stockholm, Sweden.

LA boosts public-access defibrillation

Defibrillation got major support last month with the announcement by the city of Los Angeles, California, that it will launch a municipal program to install automatic external defibrillators (AEDs) and getting broad news coverage as a result. The California community made Philips Medical Systems (Andover, Massachusetts) the specific company benefactor of the program, saying that it initially will purchase 200 of that company's FR2 (formerly known as the Forerunner) AEDs and could later expand that to 1,000 purchases of the devices.

But the more general benefactor was the AED industry because of the boost given to the concept of public access defibrillation via the coverage by USA Today in a front-page story and two additional stories in the publication's Life section.

Another major supplier of AEDs, Cardiac Science (Irvine, California), has reported numerous new contracts for deployment of its Survivalink devices in recent months, after acquiring the Minneapolis, Minnesota-based company of that name in mid-2001. The city of Boston, for example, has signed a contract for 1,100 AEDs, with the initial units being deployed in city ambulances and by the paramedic bike services, which acts as a safeguard at the Boston Marathon, concerts and other public events.

In Los Angles, the devices will be placed in a wide variety of venues, from the city's administrative offices to the zoo. Philips AEDs were chosen because of their greater ease of use and the clarity of the voice directions they provide, according to Los Angeles fire department officials. The program will cost the city about $700,000.

One of the USA Today stories focused on the fact that Los Angeles World Airports, operator of LAX, committed more than a year ago to installing the devices in its terminals – also choosing the FR2 – but that funding for the program never materialized. During the past year, there were 15 cardiac arrests at the airport, accounting for 13 deaths. The two survivors were saved with AEDs taken from planes, not installations in the terminal. About 500 cardiac arrests occur in Los Angeles each year. At the average survival rate of 5%, this translates to about 475 deaths, including many that might be avoided with the ready availability of an AED. But David Freeman, worldwide marketing director for Philips Medical, noted that the survival rates in large cities tend to be lower than 5%.

Was Philips excited about the national coverage? "Absolutely," he said, "because that means a lot of lives saved, and the technology is here and easy to use. It's not a dream." Freeman told Cardiovascular Device Update's sister publication, Medical Device Daily, that the key to such programs is placement of AEDs in areas that will put them three minutes or less from someone who has had a heart attack, with the industry hoping to see the devices as plentiful and readily available as fire extinguishers.

"This is the way communities are going to start to hear about AEDs" in general public use, Freeman said. He added that plans call for Los Angeles initially to purchase about 200 of the Forerunner devices, with the total program to be the largest of its kind in the country.

Besides being enthusiastic about the Los Angeles program, Freeman said he was equally excited about the number of public-access AED programs sprouting up around the U.S. in smaller communities, some programs even training high school students to use the devices, along with CPR. Besides citing strong sales in the U.S., he pointed to various strong "pockets" of market adoption in the UK, Germany, Italy and Australia. His ultimate hope, he said, is that public-access defibrillation programs "will become a movement."

Study: WelChol, Lipitor lower LDL

WelChol (colesevelam HCl) and Lipitor (atorvastatin calcium), taken in combination, can lower LDL cholesterol levels by 48% in patients with moderately high cholesterol – a reduction statistically superior to either therapy alone – according to a study published in the October 2001 issue of Atherosclerosis.

The study demonstrated that patients receiving this combination (3.8 g WelChol plus 10 mg Lipitor) experienced additive reductions in LDL cholesterol that were not significantly different from the maximum recommended dose of Lipitor alone (80 mg). This fits the guidelines for the new National Cholesterol Education Program (NCEP), launched last May, specifying that patients at high risk for coronary heart disease must be treated more aggressively. The guidelines say that combination therapy is a safe and effective way of lowering LDL cholesterol and reaching goal.

"The results of WelChol/Lipitor coadministration suggest that this combination may be beneficial in lowering LDL cholesterol to NCEP recommended target levels for patients with or at risk of developing CHD," said Donald Hunninghake, MD, principal study investigator and professor of medicine and pharmacology at the University of Minnesota (St. Paul, Minnesota).

This is the third such combination study with WelChol plus a leading statin demonstrating the two work better than either alone. The prior studies were conducted with simvastatin (Zocor) and lovastatin(Mevacor).