Vascular Device Forum

Cordis J and J shakeup with more executive departures

Cordis J & J announced the departure of worldwide president Tom Pope, the seventh in a string of executives to leave during an uncertain period for coronary stent technology. As reported by Forbes.com, this occurs under the circumstances of Abbott Medical's strong showing with the Xience stent which outperformed the Taxus stent from Boston Scientfic. It is predicted that Abbott will control 47% of the market by 2011 by Wachovia analyst Larry Biegelson.

Innovative technology for treatment of Varicose Veins, Spider Veins, Venous Insufficiency

Various treatments exist for symptomatic and asymptomatic lower extremity venous disorders. These include endovenous laser ablation, sclerotherapy, ambulatory phlebectomy and traditional vein stripping. Angiodynamics makers of the Venacure endovenous laser ablation system (and recent acquisition of Diomed and its EVLT technology) also distributes Sotradecol, the most common agent used in sclerotherapy.

From veindirectory.org a recent post featured information on a new product released by Vascular Technologies. The Ultroid Medical System will be used initially for the treatment of hemorrhoids but may eventualy have a more broad application that includes varicose veins. We'll have future posts on the lucrative venous therapy space. Learn more about varicose vein treatment alternatives including endovenous ablation, sclerotherapy

Speaking of Angiodynamics. We mentioned them briefly last week with regards to a voluntary recall of the Centrus dialysis catheter. Recent 2007 Q4 financials were released and our quite strong excluding ongoing costs of litigation with VNUS regarding a disputed patent infringement. The acquisition of Diomed seems to make Angiodynamics the Bully on the block in the varicose vein treatment space.

See how the street responds to the Q4 report for ANGO

Angiodynamics (ANGO): What a Recovery!

Experts suggest that a single quarter does not make a financial history and the prudent investor should not flee at the first whiff of smoke, however 2007 was not a investor confindence building year for Angiodynamics. Reaching of low stock price of 9.95 on March 10, 2008, the outlook was bleak.

However F4Q08 (quarter ending 5/31/08) results were excellent. Despite settling a patent infringement case with VNUS medical in June. Seeking alpha has the earnings call transcripts. On this news, the stock climbed to 16.19 on Friday July 25, 2008.

Recently, Forbes.com ranked ANGO 11th on its list of 200 best small companies. Things are looking up. The question is our the bad times behind and is there more upside to come with ANGO's strong position in the venous space with it Diomed acquisition and settlement of the VNUS Medical litigation. Is it a buy or sell

Loss is Win for Boston Scientific as Abbot's Xience V bests the Taxus stent

As previously reported, Abbot's Xience V stent outperformed Boston Scientific's Taxus coronary stent in the Spirit III trial. This is excellent news for Abbott. However, as reported previously, Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS™ Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.

A study from JAMA, "SPIRIT III is the first large-scale clinical trial to show that patients
have a lower risk of experiencing a heart attack, cardiac death or
re-treatment when treated with a new stent, XIENCE V, compared to the most
widely used drug eluting stent TAXUS," said Gregg W. Stone, M.D., of the
Columbia University Medical Center; chairman, Cardiovascular Research
Foundation, New York; and principal investigator of the SPIRIT III clinical
trial.

There seems to be plenty of upside for Boston Scientific as a consquequence of this study which demonstrates some performance benefit

Diamondback Orbital Atherectomy from CSI erodes Foxhollow's marketshare with Silverhawk

It appears that the Diamondback from CSI has eroded into the marketshare for lower extremity atherectomy that was preveiously held by EV3/Foxhollow's Silverhawk. The Diamondback system is an orbital atherectomy device for treatment of lower extremity athero occlusive disease. It was released in September of 2007. CSI filed with the SEC for a planned IPO in January of 2008. See more information about the technique of orbital atherectomy with the Diamondback atherectomy from CSI. Learn more details about the executive team and corporate financials for CSI.

Read more about EV3/Foxhollows 2007/Q4 results. This article nicely summarizes some of the barriers to growth that exist with directional atherectomy using the silverhawk system.

So does this all add up to the successful IPO for CSI only 10 months after the FDA granted 510 clearance for the Diamondback device. 1,700 catheters were shipped and $4.6million revenue generated at the close of 2007 (see S1 SEC filing) In VIVO Blog reports why it makes sense.

Finally, Bio Medicine reports Q1 2008 results which further notes issues such as high levels of customary inventory. ie large volumes of product sitting dormant on hospital shelves, highly incentivived-highly compensated former silverhawk reps being brought in line with industry comp norms

Diamondback Orbital Atherectomy from CSI erodes Foxhollow's marketshare with Silverhawk

It appears that the Diamondback from CSI has eroded into the marketshare for lower extremity atherectomy that was preveiously held by EV3/Foxhollow's Silverhawk. The Diamondback system is an orbital atherectomy device for treatment of lower extremity athero occlusive disease. It was released in September of 2007. CSI filed with the SEC for a planned IPO in January of 2008. See more information about the technique of orbital atherectomy with the Diamondback atherectomy from CSI. Learn more details about the executive team and corporate financials for CSI.

Read more about EV3/Foxhollows 2007/Q4 results. This article nicely summarizes some of the barriers to growth that exist with directional atherectomy using the silverhawk system.

So does this all add up to the successful IPO for CSI only 10 months after the FDA granted 510 clearance for the Diamondback device. 1,700 catheters were shipped and $4.6million revenue generated at the close of 2007 (see S1 SEC filing) In VIVO Blog reports why it makes sense

Great patient information site for heart disease

Im always looking for patient information sites that present material in easy way to understand for patients. As we know, its not easy to explain some of the complex issues of patient care in a brief patient interaction. I came across www.heartsite.com. They describe themselves as the online resource for reliable and unbiased information about heart disease. The site is full of information that is quite easy to understand with lots of illustrations, images and videos. Note the online lecture component. Give it a test run.

Bio Absorbable Stents? Maybe....

Im waiting to do a case and considering what pathology I will likely find and how to treat the vascular disease. Practicing in a Metropolitan setting we have a relatively high incidence of diabetes. Although looking at recent increases in the overall incidence of diabetes, every region in the US has a high incidence. We also have a wound care facility staffed by my practice and with that combination we see a lot of major tissue loss.

Our practice pattern has been such that before infrapopliteal options for minimally invasive interventions were available, we performed 20-30 tibial bypasses per month for limb threatening tissue loss. With the accpetance of balloon angioplasty/stenting as a technical option for this region, I have not seen a significan decline in the need to treat severe tibial occlusive disease with open bypass. Especially when it occurs in the face of a large wound which will require excellent, sustained blood flow directly to the region of tissue loss to facilitate healing. Ie, I still believe that pulsatile flow to the area of tissue loss is the gold standard for treatment in this population.

Having said that, there clearly is a role for PTA/Stent or Atherectomy for selected lesions, in selected patients. And when there is short focal disease, we are sometimes able to establish pulsatile flow to the region. However this has been a challenge in a more diffuse pattern of disease. My results with stenting this level have been excellent for immediate technical success, however I am underwhelmed with long term durability as we adhere to a diligent surveillance protocol in addition to our clinical care of the wound.. I tend to tell my residents that the symptoms at presentation, patient co morbidities are just as important as the anatomic findings in dictating what treatment will accomplish our goals for treatment.

All that said, I think that bio absorbable stents represent a possibility for addressing some of the theoretical concerns of mid and long term vessel patency after stenting in the infra popliteal space. Abbot's Absorb stent is promising to this end in some of the preliminary European data.

Here's some information from heart.org

Xience, Promus from Boston Scientific- New Drug Stents

From Abbot Medical: Once again, Abbott is leading the wave of innovation in stent technology. The XIENCE V Drug Eluting Stent's proven design combines the deliverability of MULTI-LINK VISION with a biocompatible fluorinated copolymer and everolimus to assist in increased treatment success for patients with coronary artery disease (CAD).

Abbott announced that FDA approved the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. XIENCE V will be launched in the United States immediately.

The Xience represents the fourth Drug Eluting Stent approved following the Cypher and Taxus from J&J and Boston Scientific respectively. Earlier this year the Endeavor was released from Medtronic. Interestingly, as a consequence of the original Guidant buyout deal, two identical stents will be released. The Promus from Boston Scientific and the Xience from Abbott

See Video of the stent

Vascular Device Industry Quarterly Earnings Report

Market Watch of WSJ.com fames reports that a Life Science Intelligence study predicts that the global market for percutaneous closure devices will exceed $1 Billion, yes $1 Billion by 2013.

From Market Watch Abbott pharmaceutical reports a 34% increase in 2nd quarter profits over last year. Vascular products sales increased 16% to $490 million, with sales of coronary stents increased 30% to $217 million. Abbott's new drug-coated stent, Xience, was approved for the U.S. market in early July. The product has already been on the market in Europe for some time.

Market Watch quarterly earnings from J & J. J & J. Definately one for the college fund.

Medtronics reports flat earning on charges from Market Watch