Vascular Device Forum

Conflicts of interest attract Senate attention

This is a story that has been circling for some time. Although it involves an orthopedic surgeon. The topic is germaine to all medical fields. It involves  the issue of industry support, especially with regards to ghost writing and industry supported research. Dr Tim Kuklo is the orthopedic surgeon at the center is this turmoil. He previously worked at Walter Reed and has been on faculty at Wash U. The company allegedly providing the support is Medtronic

See the complete story

New Left Ventricular assist System from Terumo Medical

Terumo Heart, Inc. today announced the discharge of the first U.S. patient implanted with the DuraHeart(TM) Left Ventricular Assist System (LVAS). The patient was discharged home on August 14th, from the University of Michigan Health System, 15 days after receiving the device.

The patient is a 62-year-old man from Livonia, Michigan, who has been suffering from heart failure for nearly 20 years. He is the first U.S. patient to receive a ventricular assist system that utilizes advanced magnetic levitation (Mag-Lev), a new, innovative type of technology.

Dr Pagani, National Co-Principal Investigator for the U.S. pivotal trial of the DuraHeart LVAS commented on the recent discharge. "We are extremely pleased with the performance of the DuraHeart and the recovery of our patient to an excellent functional state to permit discharge. We look forward to expanding upon our early experience with the DuraHeart in the near future."

The goal of these devices is to return the patient back to a relatively normal lifestyle and to provide improved "quality of life." "We are delighted that the FDA has allowed us to begin this trial with no restriction on patient discharge, which has not been true of some of the other devices currently conducting Trials in the United States," said Chisato Nojiri, M.D., PhD, Chief Executive Officer for Terumo Heart, Inc.

Earlier generation Left Ventricular Assist devices are prone to hemolysis, blood clots and mechanical failure. Significant advances have been made in the DuraHeart LVAS to potentially overcome these problems. Dr. Nojiri explained: "We have a unique pump design that combines advanced "Mag-Lev" technology and a centrifugal pump. The "Mag-Lev" allows for the complete elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. This is expected to significantly improve the clinical performance and long-term potential of this type of therapy." It has been used in more than 70 patients in Europe with the longest ongoing support over 3 years.

The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure. The National Co-Principal Investigators are Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.

Source

Top Ten Cardiovascular and Peripheral Vascular Early stage companies

Vascular Device Forum (VDF) cites an article in Medical Device Today which describes the top ten early stage Cardiovascular and Vascular companies. This list was created from presentations at the "Investment In Innovation (In3) Medical Device Summit" on June 17-19, 2008. (Part 1 of 3)

1) Arterial Remodeling Technologies tops the list. Arterial Remodeling Technologies (“ART”) is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. Many industry experts are calling ART the next best thing.

2) CardiAQ Valve Technologies

3) ES Vascular technologies develops vascular staplers for open, endovascular AAA and femoral popliteal reconstructions.

7) Protomed creates sutureless techniques to facilitate rapid and safe completion of vascular anastomosis

Equine pericardium lined stents...The Answer??

The Over and Under Pericardium Covered Stent (PCS) is a unique coronary stent from ITGI Medical. It is designed to create a barrier between the blood vessel wall and lumen and theoretically decrease the risk of re stenosis. This device is indicated for the treatment of de novo, recurrent vein graft lesions or perforations. Are equine pericardium lined stents the answer to restenosis

In other news it is reported by the Dow Jones Newswire that the Cleveland Clinic Foundation has announced plans to encourage interventional cardiologists to choose from an approved list of drug eluting stents which does not include the Boston Scientific TAXUS. Boston Scientific previously signed a deal in 2006 to serve as the preferred vendor.

Johnson and Johnson, Medtronic and Abbott will be on the preferred list. Interestingly, a recent study showed a performance advantage for the Abbott Xience vs the Taxus. Boston Scientific has a distribution agreement with Abbott to distribute an identical stent called the Promus.

Avantage: Abott Medical

Image Abbott

The History of Angioplasty 101

The minimally invasive treatment of peripheral and coronary vascular disease is a billion dollar industry.  Lost in the current landscape of daily innovation is an appreciation of the relatively short period of time that has passed since the first coronary angioplasty in Sept 16, 1977 by Andreas Gruentzig. Angioplasty.org presents a timeline of the history of catheter based intervention.  Learn more here...

If you're a huge fan of history, you may even purchase a DVD which chronicles the process.

Finally, hear some thoughts on the evolution of angioplasty from some of the opinion leaders of interventional cardiology here

Its always amazing to learn how fast innovation accelerates after seemingly insurmountable obstacles are overcome

Foxhollow/EV3 Silverhawk vs CSI Diamonback-More behind the scenes positioning

Vascular Device Forum (VDF) continues to get information on the allegations against former members of Foxhollow/EV3 management and sales force team. The allegations in the posted document refer to EV3/Foxhollow's misappropriation of trade secrets in addition to the allegations of opinion leader poaching that our post described yesterday.

Further allegations suggest that CSI attempted to gain unfair advantage by hiring members of Fpxhollow's management team who systematically obtained vital client relationship information prior to departing EV3 Foxhollow:

Immediately prior to Collins resigning his position at FoxHollow he required each FoxHollow Regional Manager then reporting to him to prepare and deliver to him a “business plan.” Collins’ superiors did not ask him to gather business plans from his direct reports. The business plans contained vital confidential information owned by FoxHollow including, but not limited to, sales information, revenue targets, lists of FoxHollow’s customers, Key Opinion Leaders (physicians who heavily utilize the SilverHawk™ device), target customers and marketing strategies. Given his impending departure, at the time Collins requested and obtained such business plans the only reason to collect this information was so he could use it at CSI to unfairly complete with EV3/FoxHollow.

It's clear that the potential for the application of atherectomy technology is enormous and the potential economic return is substantial. And the individual financial rewards for being the first in on a startup opportunity like CSI or Pathway medical are quite motivating

Read this section of the source legal document

Sometimes there's more to Medicine...A lot more

Sometimes in our hectic day to day existence of taking care of patients and juggling the chaos of life in general, we forget what our purpose is. Several months ago, Ron Fairmen MD, Chief of the Vascular Service at Penn presented his experience or volunteering his time to care for our brave injured soldiers in the Iraqi and Afghanistan conflict at  Landstuhl Regional Medical Center (LRMC) in Landstuhl, Germany

He had tons of great stories about the challenges that present in that setting and about some of the thoughts that occur under strained circumstances. He was quite surprised with the tremendous injury severity caused by the IED, the predominant agent involved in severe blast trauma. Even more so, he was overwhelmed with the comraderie and bravery of the young men and women who frequently asked when they could return to their platoon shortly after surviving near death experiences.

Angioplasty.org has a good article describing other surgeons experiences with this unique program by the SVS (Society of Vascular Surgeons)

Behind the scenes with Diamondback from CSI and Silverhawk from EV3/Foxhollow

Vascular Device Forum (VDF) is always interested in the behind the scenes industry happenings. I recently received this interesting document from a reader.The document describes some of the apparrent jockeying for the attention of key opinion leaders with regards to new and evolving technologies such as atherectomy. Key opinion leaders refers to high volume clinicians as well as prominent academics/clinicians that are able to drive volume for device usage either directly through their practice or influence industry usage through their position in the different medical communities ie cardiology, vascular surgery, intereventional radiology.

Read the following exerpt:

b. Aaron Lew
Lew sent some e-mails which suggested that he may have contacted
ev3/FoxHollow SilverHawk customers to obtain their endorsement of him as a
salesperson for a PAD treatment device like SilverHawk or Diamondback. While
these e-mails may suggest an improper solicitation of sales of the Diamondback
product before he joined CSI, they may only be an attempt to alert potential
references that they may be contacted by CSI during the employment process.
Further discovery may shed additional light on what Lew was attempting to
accomplish.
In any event, even if Lew violated his duty of loyalty any damages could be
adequately covered by monetary damages and the Plaintiffs were not irreparably
harmed. His termination from CSI would not remedy his prior actions. In
addition, there is no evidence that Lew is yet a party to this suit.


4. Trade Secrets
If Plaintiffs' trade secrets are transferred by former ev3/FoxHollow
employees to CSI or are used by the former employees or CSI to market CSI's
Diamondback product, it would be a violation of the FoxHollow employment
agreement. Such violation would cause irreparable harm to Plaintiffs and the
five Dahlberg factors would be resolved in favor of a restraining order.


5. Future Recruitment of ev3/FoxHollow Employees by CSI
If current CSI employees who are subject to the FoxHollow employment
agreements directly or indirectly solicit other ev3/FoxHollow employees it would
be a violation of the FoxHollow employee agreement. Such conduct shall be
prohibited because it would cause irreparable harm and the five Dahlberg factors
would be satisfied. There is little burden on CSI to simply prohibit such
conduct and have all recruitment, if any, handled by persons not covered by the
ev3/FoxHollow agreements.

In this document Foxhollow/EV3 make an effort to forbid two individuals who are apparrently former Foxhollow employees from poaching thought leaders after they move to CSI. These maneuvers obviously happen especially when a new technology with similar application is introduced like the atherectomy space with Diamondback and Silverhawk. It's obviously a goal of the new entrant into the field to entice some big accounts away and hope that the physician is attached to the clinical rep or field specialist and if one of the physicians is a regional or national thought leader, even better.

It just doesnt seem like that principle is completely applicable from the standpoint that Silverhawk versus Diamondback is not an either or proposition in my mind. Directional cutting athererectomy of silverhawk has a different niche space compared to the touted calcium cutting benefit of the Diamondback system. In fact, if you read some of the product description material for the Diamondback, the descriptions suggests that the excellent ability to cut calcium correlates inversely with the inability to cut normal and atheromatous tissue. It's reported that the results with the Diamondback system are much less impressive in atheromatous tissue.

View the actual source legal document to learn more

CT angiography of the heart-What's the role?

A recent article in the New York Times raised a controversial question about the role of CT angiography of the heart. The article described the potential for over use especially in settings where the ordering physician has economic gains from the performance of the test. The article was quite critical of some cardiologists. Read excerpts from the article here

A number of responses have been published supporting different opinions on the topic.

On the opposite end of the spectrum at angioplasty.org, a strong argument supporting the selective use of CT angiography was presented. The article refutes claims that CT angiography is an overused, unproven technology.

Interestingly, you find that the vascular imaging lobby is quite strong and ready for a scrum. Dr Z's medical report is one attempt at a disinterested opinion on the hot button topic. He suggests that as always, if there is any doubt in your mind about the need for a test or some inappropriate incentive-Ask twice and verify with a second opinion.

Surely theres more to come about this sensitive topic in the current medical environment

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?