Vascular Device Forum

Medical Malpractice in Vascular Surgery-The Changing Dynamics

Although it's a topic no one really wants to talk about, medical malpractice remains an important discussion for medical providers.  The crisis of medical litigation which prompted mass exodus of physicians from crisis regions like Pennsylvania, West Virginia and Florida still exists. For a vascular surgeon practicing in greater Philadelphia Pennsylvania, an experienced surgeon with no cases, who has been practicing for over 5 years can expect to pay a malpractice premium of $60-80,000 There appears to be some plateauing of the number of annual suits in many states. However as anyone who has been through the unsettling process of a plaintiff's claim of negligence; a single experience into this dark realm of our profession is sufficient motivation to learn more about avoiding the situation

Endovascular Today recently dedicated a supplement issue to this topic. It's a must read for any cardiologist, interventional radiologist or vasculcar surgeon performing endovascular and catheter based interventions. Several highlights of the supplement include A Primer on Malpractice Litigation, Expert testimony, How to prepare and a round table discussion which uses an actual case study format.

Particularly interesting is the round table discussion that describes some of the issues of standard of care that are evolving in this fluid environment of evolving technology and skill level. For example, off label use of devices, use of hybrid devices for EVAR and others. Does a poor outcome, indicate malpractice. Noncompliant long term follow up after EVAR. Expert witness variance from state to state

I encourage everyone to consider reading this brief overview that provides a timely resource on Medical Malpractice Litigation

CSI Replidyne Reverse Merger- Life for the Diamondback

Title CSI Replidyne Reverse Merger- Life for the Diamondback   Cardiovascular Systems CSI on the verge of an IPO in late 2008 announced an agreement on Nov 3, 2008 to undergo a reverse merger with Replidyne, a biotech company which failed in FDA phase III trials of its trial compound-faropenem. To learn more about other options for CSI and Replidyne On Feb 25, 2008 the two companies announced completion of the transaction. Cardiovascular Systems Inc as the new company will be called, now enters the public trading domain as CSII. In this transaction, Replidyne provided $37 million in net assets primarily cash for a 17% state in the post merger entity.   The diamondback athrectomy device is the company's core product. Athrectomy, a technique of shaving down atherosclerotic debris within a diseased and blocked blood vessel, is an minimally invasive alternative to angioplasty and stenting. Currently, it is FDA approved for usage in the peripheral circulation of the lower extremities. Future applications for the heart coronary system may be conceivable with further research and development   The merged company will be headed by the management team of CSI lead by David L Martin, CEO.  The combined board of directors consists of nine members, including two directors from Replidyne, Edward Brown and Augustine Lawlor. Glen D. Nelson, M.D., is chairman of the board. Other directors are Brent Blackey; John Friedman; Geoffrey Hartzler, M.D.; Roger Howe, Ph.D.; David Martin; and Gary Petrucci.   As of Dec. 31, 2008, more than 14,700 devices had been sold to approximately 400 hospitals since the September 2007 product launch. This is fantastic news for the CSI team. It seems to offer them some vital capital at a juncture when they may need to refill the tank for infrastructure, sales and marketing. As you know, Mr Martin, was former COO of Foxhollow and was instrumental in launching the Silverhawk device, an early generation peripheral atherectomy system that gained significant market share before the company was acquired by EV3. In its quarterly report, EV3 estimates that revenue from the Silverhawk device is 75% from peak activity. Several questions come to mind. (1) Is there medical evidence to support the benefit of athrectomy in the peripheral vascular system. The Diamondback system is touted as a solution for treating athero-occlusive blockages associated with heavy calcification. A problem that has previously challenged the techniques of balloon angioplasty and stent placement in the lower extremities. To date, there is limited research to support the benefit of angioplasty, stenting or atherectomy when compared to the gold standard of peripheral surgical bypass with autogenous vein. (2) At this point in athrectomy technology, is the diamondback system just a new variant of the silverhawk--marketed to have technical advantages in the relatively smaller segment of peripheral vascular patients who have dense calcification that is prohibitive for angioplasty and/or peripheral bypass. My guess is that the CSI will market the Diamondback as the "must have" new product to cardiac catheterization labs and soon market watchers will see a brisk climb in revenue from new accounts. Especially after the CSI Replidyne merger creates a fresh capital infusion to flood the market with an incentivized sales force and marketing support. But, where is the randomized prospective research data that will support wide spread application of the system by multiple specialist (The "Holy Grail" of long term device success)?? Or is the CSI Diamonback detined for the same face as the EV3/Foxhollow Silverhawk device-Brisk sales from new accounts only to collect dust on the back shelf of the cath lab as proceduralist lose interest for the newest toy  and ask for the familiar balloon, stent or surgical knife.