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February 14, 2011 -- 5:00pm EST Laser Wars: Volcano Vindicated on OCT Trade
Secret Suit In fact, Dr. Julio Palmaz, co-inventor of the first angioplasty balloon exandable Palmaz-Schatz stent, told me last year that the biggest thing an inventor needed to understand was just how much time he'll be spending in court, defending his patent. That certainly is the case with the laser technology used in a new generation of intravascular imaging catheters, called OCT (Optical Coherence Tomography) which can be used to image the inside of a coronary artery, look at a stent's positioning, whether it has healed correctly, etc. So here's the "prequel". First Volcano acquired CardioSpectra in December 2007, followed by Axsun Technologies a year later, setting course for development and manufacture of a future OCT technology. Another year later and St. Jude Medical acquired LightLab, which had been developing OCT and had just gained FDA approval. The complicating factor was that Volcano's new subsidiary Axsun manufactured LightLab's laser! So a number of law suits were filed on both sides and the results of the latest round were announced last week. Both companies issued press releases and it seemed that both were claiming victory (see "St. Jude Versus the Volcano"). The Court did find that Volcano and Axsun had violated the unfair competition clauses of Massachusetts State Law 93A, and fined them $600,000. Volcano also has to pay for St. Jude's mandatory attorneys' fees and costs -- the price tag: $4.5 million. (Another example of why my mother was right and I shoulda been a lawyer!) But importantly for Volcano, the Court agreed with a jury verdict from October and threw out any claims of patent or trade secret violation. As for the fines? LightLab originally claimed damages in the amount of $200 million and legal fees of $8.9 million, so the Court settlement was for half the legal fees and 0.3% of the damage claims. Volcano's General Consul and Senior VP, Darin Lippoldt stated in an email to Angioplasty.Org that "Volcano is well-positioned financially, and this does not impact us in the short or long term." And he wrapped up the case findings, as follows:
There still is outstanding litigation (does it ever stop?) but the important news for Volcano is that they are now free to move forward with their OCT platform. According to Lippoldt:
Need I say, stay tuned? Like a laser... « permalink » « send comment » « back to top »
February 8, 2011 -- 8:15pm EST Fractional Flow Reserve: A "How-To" Guide
for Cardiologists The results of the by now well-known FAME study indicate that a third of the blockages between 50% and 90% (as seen on the angiogram) actually had an FFR measurement of greater than 80% (meaning that the obstruction of flow was less than 20%, even though the blockage looked more significant on the angiogram). Most importantly, treating those blockages with angioplasty and stenting resulted in worse outcomes at one year -- results which have remained constant now three years later. For more information, read our exclusive interview with Dr. Nico Pijls, co-principal investigator for FAME. The bottom line is that fractional flow reserve guidance reduced the number of stents used by one-third while producing improved clinical outcomes by...one-third. A no-brainer: better results for patients, lower costs for the healthcare system. What's not to like? So in the December 1 issue of Catheterization and Cardiovascular Interventions (Volume 76, Issue 7, pages 978 –985), colleagues of Dr. Pijls, headed by Dr. Bernard De Bruyne of Belgium, published a "how-to" guide on FFR titled, "Practical tips and tricks for the measurement of fractional flow reserve". The abstract states:
FFR wires are manufactured by Volcano Corporation (NASDAQ: VOLC) and St. Jude Medical (NYSE: STJ), via St. Jude's acquisition of Radi Medical Systems of Sweden. Catheterization and Cardiovascular Interventions is the official journal of The Society for Cardiovascular Angiography and Interventions (SCAI). The advantages of FFR in decision-making for multivessel PCI are well-documented. Learn how to do one today! |
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