Year 2007 marks the 30th year of this publication's analysis of U.S. and international med-tech, with Biomedical Business & Technology having issues of our predecessor newsletter beginning from 1983.

To highlight what has or has not changed in this industry, we here provide excerpts of news items from these earlier publications.

November 1983 —

"TRENDS IN OPHTHALMOLOGY

"Several new YAG lasers were shown at the AAO [American Academy of Ophthalmology meeting]. LASER INDUSTRIES (Israel), world's largest producer of CO2 lasers drew enormous crowds with its retrofit Sharplan 702 Q-switched system that will be offered at $25,000 - well below "full-function" YAG lasers, typically priced around $75,000. In addition to previewing its YAG, LASER INDUSTRIES also introduced the Sharplan 700A Argon system... .

"Another entry into the YAG retrofit market is VECTOR TECHNOLOGIES INTERNATIONAL (FTI, Fountain Valley, Calif.) with the $55,000 Q-switched Capsular. The unit is based on LASAG's (Switzerland) full-function laser and specifically designed for office capsulotomy procedures... .

"Other new YAG laser introductions include NIDEK's (Japan) system that will be built in its new Silicone Valley, California facility ZE

ISS (West Germany) showed a $55,000 YAG laser and LASERSCOPE (Santa Clara, Calif.) introduced the $110,000 Ophthos, a twin crystal photosurgical system that integrates a three frequency panspectral laser capability into one unit.

"With at least 18 ophthalmic YAG laser manufacturers and developers in the market, the most important factor for survival is how soon the FDA will approve these devices. Currently, each manufacturer may place only 20 units in the U.S. as part of an investigational device exemption. The FDA's Ophthalmic Advisory Panel recommended earlier this month to approve AMERICAN MEDCICAL OPTICS" Yag 100 system for posterior capsulotomies. The device had been evaluated in mover 500 patients for six months or longer. There is speculation that the first official market approvals will be granted in mid-1984.

"TRENDS IN CARDIOVASCULAR DISEASE TREATMENT...

"Approximately 1.8 mln. Cardiovascular procedures will be performed this year in the U.S. These include 241,000 open heart surgeries (175,000 coronary bypasses), about half a million cardiac catheterizations (includes digital subtraction angiography) and 220,000 peripheral vascular procedures... .

"The first PTCA [percutaneous coronary angioplasty] procedure independent of surgery was performed in 1977 in Europe. Improvements in catheter design such as steerable systems and low profile catheters with stronger balloons have helped to achieve an over 80% success rate, an emergency operation rate of less than 7% (the open heart team, therefore, needs to be on standby during the procedure) and a mortality rate of 1.2%. The most experienced centers have less complications. Overall, long term vessel patency is over 70%.

"Typically, $700-750 in consumables is spent per PTCA procedure for the dilatation catheter, guiding catheter, guide wires, introducers, etc. Experienced centers need about 1.5 PTCA sets per procedure; cardiologists at the beginning of the learning curve require more than that... .

"The U.S. accounts for about 75% of the overall PTCA market: 17,500 procedures resulting in 42,000 catheter kit unit purchases ($29.4 mln) in 1983. Companies such as CORDIS, SCI-MED MEDICAL SYSTEMS, AMERICAN EDWARDS LABORATORIES, MEADOX MEDICALS and DATASCOPE are expected to enter the PTCA market, although none is currently in human clinical in the U.S... . .laser catheters, to vaporize atherosclerotic plaque from vessel walls, are under development at several angioplasty catheter manufacturers and laser firms... .

"There are many unanswered questions relating to the effect of laser vaporization on tissue. It will take at least 2-3 years before its histological effect on vessel wall and plaque buildup will be known.

In addition, there is no consensus of opinion regarding the best laser source (Argon, YAG, CO2) or the optimum method to control laser energy delivered. It will obviously take years before a product will have received FDA market approval. Current estimate is that a 1985 market introduction might be possible for a peripheral dilation device; 1986/7 for a coronary laser catheter."

[Editor's note: The November 30 issue listed 10 IPOs, the largest, $4.5 million by SCOPAS TECHNOLOGY, the maker of a gaseous sterilant, instant dental X-ray and zeiollite-based absorbents; the smallest, $1.6 million by FERTIL-A-CHRON, maker of a fertility thermometer and monitor.]