Cath Lab Digest

Boston Scientific beats J&J in Battle for Guidant

Heart device maker Guidant Corp. agreed to be bought by Boston Scientific Corp. for $80 per share, or about $27 billion, and terminated an agreement to be acquired by Johnson & Johnson. The move came hours after J&J, which had been offering to buy Guidant for $71 a share, let a midnight deadline expire without responding to Boston Scientific's rival bid.

In a statement, J&J said it had determined not to increase its last offer for Guidant Corp., because to do so would not have been in the best interest of its shareholders.

The agreement is the latest turn in J&J's 14-month attempt to take control of the maker of implantable heart defibrillators and products used in angioplasty.

As part of the deal, Boston Scientific entered into an agreement with Abbott Laboratories, under which Boston Scientific agreed to divest Guidant's vascular intervention and endovascular businesses, while also agreeing to share rights to Guidant’s drug-eluting stent program.

Corindus, Cath Lab Technology Firm, Strengthens U.S. Presence

Corindus, developer of remote control technology for the cardiac catheterization laboratory, announced the opening of U.S. headquarters in Auburndale, MA for the management of sales, marketing and clinical affairs. Originally established in 2002 as NaviCath, the company was founded within the framework of the Technion Entrepreneurial Incubator Company (TEIC) in Haifa, Israel.

Corindus holds a patent for Remote Control Catheterization technology. Its CorPath catheter manipulation system allows physicians to advance and torque coronary guide wires and stent systems in a patient’s artery from a remote location. The system is non-invasive and accommodates all state-of-the-art interventional cath lab devices.

With the increasing volume and complexity of interventional procedures, the health hazards associated with the exposure of physicians and staff to radiation has become a significant concern. As remote control catheterization becomes standard practice, the risks of radiation can be significantly reduced. Additionally, fatigue and back pain, a major problem for operators caused by the need to wear lead radiation protection garments, can be virtually eliminated.

Initial clinical trials with CorPath successfully demonstrated its safety and efficacy. Further clinical study to obtain FDA marketing approval is underway.

CorPath mechanically maneuvers devices through patients’ arteries as specified by the physician at a remote workstation. The proprietary technology utilizes physician fluoroscopic control similar to routine practice to allow maneuvering and torquing of cath lab devices. Initial clinical trials have demonstrated CorPath’s safety and efficacy. Unique to CorPath is the simplicity of integration into existing cath lab systems. The CorPath system requires regulatory clearance and currently is used for investigational purposes only.

The TAXUS Stent System Shows Excellent Results in Small Vessels

Boston Scientific announced that the data from its TAXUS Clinical Trial Program, including the meta-analysis, shows excellent efficacy and safety in treatment of small vessels (< 2.5 mm diameter).¹

The large-scale, Johnson & Johnson-sponsored REALITY study (n = 1,353 across 88 centers worldwide) directly compared the TAXUS and Cypher* Stent systems in small arteries. The REALITY study confirmed the excellent clinical outcomes with the TAXUS Stent system in small vessels.²

Recently, the de-facto single-center ISAR SMART study compared Taxus and Cypher Stent systems in small vessels, which included patients with arteries similar in size to REALITY but in less complex lesions. This study, conducted by Professor Adnan Kastrati from the German Heart Centre, Technical University, Munich, Germany, failed to prove non-inferiority of the TAXUS versus the Cypher Stents system in small vessels.³

Dr. Donald Baim, Brigham and Women's Hospital, Boston, MA, commented that the data from the small ISAR SMART study is at odds with the large body of evidence from the TAXUS Clinical Trial program, including those data from the small vessel meta-analysis. Dr. Baim further suggested that we should therefore temper the ISAR SMART findings, in which routine angiographic follow-up led to an unheard of 100% rate of conversion from angiographic restenosis to target lesion revascularization, in the TAXUS arm. This pattern suggests that the ‘occulo-stenotic reflex’ was at play, compared to the usual picture of a 50% conversion rate, said Dr. Baim.

According to the evidence-based medicine clinical trial scoring system available on TCTmd.com, the ISAR SMART study scores only 3 out of 10 points and its outcomes should therefore not be used to direct clinical practice.⁴ Prof. Sigmund Silber, author of the scoring system and Chairperson of the European PCI guidelines, said ISAR SMART study does not have a primary clinical endpoint, is a de-facto single-center experience without validation from an external, independent core catheter lab. Thus, it is attributed a low score according to the scoring system.

References

1. TAXUS meta-analysis II, IV, V, VI presented by G. Stone at ACC 2005.

2. REALITY study presented by M.C. Morice at ACC 2005.

3. ISAR SMART is an independent study conducted by Pr Kastrati / Mehilli J, Dibra A, Kastrati A et al. Eur Heart J 2006; online.

4. Silber Score on tctmd.com.

5. Morice MC. Stenting for small coronary vessels. J Invasive Cardiol 2003;15:377-379.

* Cypher is a registered trademark of J&J Cordis

Witt Biomedical and GEMMS Announce Marketing and Technology Partnership

New Alliance Establishes a Continuum of Care between the Hospital and Ambulatory Cardiology Practice

Witt Biomedical, focusing on cardiovascular enterprise technology, and GEMMS, developer of a fully integrated, cardiology-specific electronic clinical information system, announced a marketing and technology partnership to benefit cardiovascular physicians and patients. Witt and GEMMS will discuss the advantages of the new partnership at ACC 2006.

According to Witt Biomedical President Mike Wolfe and GEMMS CEO Rodger P. Pinto, PhD, the alliance presents a unique opportunity for the two companies to create a continuum of care between cardiovascular testing and treatment in the hospital and care provided in the physician practice.

Wolfe explained, Our technologies complement each other in ways that will directly enhance workflow for cardiologists. GEMMS’ single-point decision system in the ambulatory cardiology practice, GEMMS|One, will provide Witt’s cardiovascular enterprise system in the hospital with the patient’s history and procedures, verification of medical necessity, and other information required to create a comprehensive record. In turn, Witt will close the loop by sending the findings of studies, tests and therapies, the transcription report, discreet data, and other pertinent details to GEMMS|One.

Pinto agreed, noting, By sharing information and seamlessly integrating our technologies, we can achieve our shared vision to provide cardiologists with complete access to critical patient information, ranging from the office visit to non-invasive cardiovascular testing to the cath lab and back to the physician practice. This holistic view of each patient’s case will empower the cardiologist to make faster, more confident diagnoses and decisions."

Janus Tacrolimus-Eluting Carbostent Demonstrates Excellent Safety Profile and Clinical Efficacy

First Six-month Clinical Findings from e-Janus Registry Presented at JIM Congress in Rome

Sorin Group, Europe's largest medical technology company specializing in the treatment of cardiovascular diseases, presented the first six-month clinical results from its e-Janus international "real-world" registry. The data, presented at the Joint Interventional Meeting (JIM) in Rome on February 17, 2006, confirm that the Janus Tacrolimus-eluting Carbostent provides an excellent safety profile and clinical efficacy for the treatment of "real-world" patients, including the high-risk AMI (acute myocardial infarction) patient population.

While still recruiting, the e-Janus registry has currently enrolled over 2500 patients at more than 80 centers worldwide (except the U.S. and Japan). Six-month clinical follow-up on 587 patients were presented by Dr. J. Koolen (Eindhoven, The Netherlands), the Principal Investigator (PI) of the study.

In the overall population analyzed (587 patients), Dr. Koolen reported a 4.3% major adverse cardiac events (MACE) rate and a 3.1% target lesion revascularization (TLR). MACE includes death, myocardial infarction (MI; Q-wave and non-Q-wave) and target lesion revascularization.

Out of the 587 patients who had completed the six-month follow-up, 31% were diabetic patients, 50.4% were patients with multi-vessel disease and 23% percent of patients presented with an acute myocardial infarction.

Dr. Koolen highlighted the results achieved in the AMI patient subset, with a 3.0% MACE rate at six-month follow-up. In these 133 AMI patients, the TLR rate was 2.2% and, more importantly, the late stent thrombosis rate for this high risk subgroup was 0%.

e-Janus is a multi-center, prospective registry, designed to collect real-world clinical outcomes in more than 2500 patients with coronary artery disease at more than 100 centers worldwide, except the U.S. and Japan. e-Janus is based on electronic CRFs, with a 3% site monitoring and with an independent CEC (Clinical Events Committee) reviewing and adjudicating adverse events.

OmniSonic's Resolution® Endovascular System Transitions to Full U.S. Market Release

OmniSonics Medical Technologies, Inc. announced that it has transitioned to a full U.S. market release of the Resolution® Endovascular System. The full market release follows the completion of a limited release that commenced upon FDA clearance in December 2005 for use in the treatment of thrombosed, synthetic dialysis access grafts. OmniSonics has initiated the expansion of the treatment of patients at additional healthcare facilities and will continue to roll out the Resolution Endovascular System as the Company's sales and operations infrastructures expand.

In occlusions that varied in age from several weeks to three months, the Resolution Endovascular System consistently re-established flow and resolved the clot in less than six minutes of application time. In addition to clearing aged-mature thrombus, physicians reported successful clot resolution and flow restoration in procedures where the patient was referred for treatment after having previously failed treatment utilizing another percutaneous thrombectomy technique.