EV3 and Foxhollow Company Mergery-Why?

On July 22, 2007 EV3 and Foxhollow Technology announced completion of an agreement for merger which had long been considered under discussions. The discussions were long rumored to have been taking place. There were some obvious synergies between the companies. There were rumors that  EV3's Spider AntiEmbolic Device (AED) would be packaged with the Foxhollow Plaque Excision device.

One of the known complications of the atherectomy procedure is peripheral embolization. In the TALON study, the incidence of embolization was approximately .1-.2%. My anectdotal experience is that the incidence of atheroembolism is higher. Its is suggested that failure to repack frequently and excessively rapid advancement of the device is the cause of embolism.

I think that it is likely that the incidence of embolization could potentially be higher in the early learning curve phase of device usage. I had a short conversation with an early user/consultant of the company who suggested that he has never seen embolization. Personally, I question the recollection of this interventionalist.

Another experienced early user wrote the following:

How Distal Anti-Embolic Interventions Can Aid Patients
The emergence of distal protection devices (DPD) has raised concerns about the incidence of distal embolization (DE) during all of our vascular interventions.^21-22 Distal macro- and microembolization can be particularly catastrophic in the CLI patient with poor and oftentimes only a single, vessel runoff. The Spider FX (ev3, Inc.) is a user-friendly DPD system designed primarily for coronary and carotid artery stenting but it is now seeing expanded use with CLI. Vascular interventionalists can position the fine mesh net filter system before intervention in distal vessels between 3 and 7 mm, and allow capture and removal of macro- and microembolic debris as small as 100 microns created during the intervention.
       This DPD strategy has allowed vascular surgeons to perform more aggressive plaque debulking and interventional strategies with less risk of distal embolic injury to the already compromised downstream microcirculation. Distal protection devices have become mandatory during carotid stenting and are common in complex coronary interventions. I now utilize a DPD in the majority of my CLI interventions. In my opinion, it allows even more aggressive revascularization and facilitates improved outcomes. I predict widespread adoption of this DPD strategy in treating CLI.

       Dr. Allie is the Chief of Cardiothoracic and Endovascular Surgery at the Cardiovascular Institute of the South in Lafayette, La.

Im looking for some commentary on the experience of users with Silverhawk and atherectomy. Distal protection or not. Selective; under what circumstances. What device would you use?

Comments

[CW]

EV3 is obviously having financial problems. They are not paying their employees back their expenses. It is like they are trying to put it off until the beginning of the year so EV3 will show a profit for the 2008 year. They have owed me over $3,000.00 and I can't get them to tell me why I have not received it! I can't get anyone to call me back about this debt owed to me by EV3. I also heard that they owe one of their Dr. over $22,000.00 for talks he has already done for EV3! I think they are trying to get MedTronic to purchase EV3 and they are attempting to hold out on expenses so that EV3 will show a profit at the end of this quarter. I also heard that if EV3 is not sold, EV3 is going to fold.

[lee]

Ive heard that from some of the folks within the organization. I just think that the acquisition of foxhollow was a questionable tactic. The promotion of the silverhawk product is absent in my locale