BioHorizon » Device

DePuy Spine’s Charite Artificial Disc for Replacement of Spinal Discs

admin — Tue, 26 Oct 2004 18:38:17 +0000

On October 26, 2004 DePuy Spine Inc. announced that the FDA had approved the Charite™ Artificial Disc. The Charite Artificial Disc, a device made of two metallic endplates and a movable high-density plastic center, is the first FDA approved artificial replacement for spinal discs. The standard surgical intervention for this indication is lumbar fusion surgery which limits range of motion and may have consequences for discs above and below the fusion site. DePuy maintains that once implanted the Charite™ Artificial Disc is designed to help align the spine and preserve its ability to move. We have assigned this technology 90 points for innovation.

The burden of illness associated with low back pain in the United States is substantial. Back injuries have been the leading cause of disability in the United States in the under 45 age cohort and the most expensive health care problem for the 30 to 50-year-old age group. In 1995 low back pain accounted for almost a quarter or $8.8 billion of total workers’ compensation payments. Spinal fusion surgery, a common surgical treatment for low back pain or degenerative disc disease, is performed at least 200,000 times per year in the United States. This corresponds to a procedure incidence of 69/100 000 and a BioHorizon burden of illness score of 25.

In March 2004, clinical trial data comparing artificial disc replacement to spinal fusion surgery was presented at the 20th Annual Meeting of the AANS/CNS. DePuy indicated that patients treated with the Charite artificial disc maintained flexibility, experienced improvements in pain and function, and left the hospital sooner and were more satisfied with the procedure than spinal fusion treated patients. Data from this trial formed part of the Premarket Approval Application (PMA) submitted to the FDA earlier this year. Based upon FDA approval, we have scored the efficacy variable at 100.

Demand/Diffusion assessments around this emerging technology are problematic. Estimates by industry analysts span a range from between 100 million and 1 billion dollars per year. Competition from evolving minimally invasive fusion procedures may play a role. We currently score the demand/diffusion variable at 25.

The BioHorizon Emerging Health Technology Impact Score for the Charite artificial disc is currently 60, placing it in the Moderate/High Impact category. Health services delivery clients should commence preliminary assessment activities focusing on their spinal surgeons’ plans for integration of this disc replacement into practice.

Technology Details
Target Disease / Indication: Low Back Pain/Degenerative Disc Disease
Technology Classification: Device
Body System: Musculoskeletal
Program Area: Surgery/Orthopedics
Regulatory Status: Approved
BioHorizon Impact Score: 60/100-Moderate/High Impact

Cordis Carotid System for Carotid Artery Disease

admin — Wed, 21 Apr 2004 17:52:17 +0000

On April 21, 2004 Cordis Corporation announced that the FDA’s Circulatory System Devices Panel had recommended approval of the Cordis Carotid System. Cordis’ pre-market approval application drew upon results of the SAPPHIRE Study, which included 334 high-risk surgical patients randomized to receive the stent with embolic protection vs. the traditional carotid endarterectomy. According to Cordis, the results showed the Carotid System to be as effective as surgery in restoring carotid artery blood flow. Also, a lower incidence of associated major adverse events was noted with the Carotid System. Post-treatment follow-up rates of serious complications such as heart attack, stroke, and cranial nerve damage were lower in patients who received a stent compared with those treated surgically. The FDA panel specified some conditions for approval including: a clarification of eligible patients, a post-market patient review, and the use of the system’s distal protection device to reduce the risk of stroke.

The Cordis Carotid System is comprised of the Precise® Nitinol Self-Expanding Stent and the Angioguard™ Emboli Capture Guidewire. These products are currently approved outside the U.S for use in carotid arteries. The Angioguard is delivered beyond the lesion, where it opens into a tiny perforated basket designed to catch plaque particles dislodged during the angioplasty and stent procedure, while allowing continuous blood flow. Once the stent is implanted to hold the artery open, the protective basket is closed and removed. Cordis has positioned its Carotid System as a minimally invasive alternative to carotid endarterectomy in high-risk patients with carotid artery disease.

Carotid artery disease refers to a buildup of atherosclerotic plaque (fatty material) in the neck’s carotid arteries that supply blood to the brain. In some patients, pieces of this plaque may break off or embolize and cause a stroke. According to CDC surveillance data, stroke is the third leading cause of death in the U.S after heart disease and cancer. Some estimates place the number of carotid endarterectomies performed annually in the U.S in the 100,000 range.

Clients with significant CVT surgery exposure should review carotid endarterectomy volume. Some preliminary clinical epidemiology detailing numbers of procedures on high risk patients is suggested at this time. Biohorizon recommends consultation with CVT surgeons concerning plans for device use if final FDA approval is obtained.

Technology Details
Target Disease / Indication: Carotid Artery Disease
Technology Classification: Device
Body System: Cardiovascular System
Program Area: Surgery/CVT Surgery
Regulatory Status: Investigational
BioHorizon Impact Score: 45/100 – Moderate

Taxus Express

admin — Fri, 05 Mar 2004 20:57:32 +0000

On March 4, 2004, Boston Scientific announced that Taxus Express, its paclitaxel-eluting stent system for the treatment of coronary artery disease, had received FDA approval. The company indicated that it planned to launch Taxus Express in the United States immediately. Cordis Corporation’s Cypher™ stent (see Week and the newly approved Taxus stent are currently the only FDA approved drug-eluting stents available for use in the United States.

Unlike traditional or ‘bare metal’ stents, the Taxus stent is coated with a substance named paclitaxel and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the paclitaxel into the vessel wall to stop the growth of scar tissue which causes restenosis. The pivotal Boston Scientific sponsored Taxus IV clinical trial reported an in-segment (stented vessel segment plus 5 mm beyond each end of the stent) binary restenosis (50% or greater vessel re-occlusion) rate of 7.9% in the Taxus group compared with 26.6% in the control group (P=<0.0001). The study also reported a target lesion revascularization (TLR) rate of 3.0% in the Taxus group compared with 11.3% in the control group (P=<0.0001). TLR (or retreatment) rate is one of the most accurate indicators of the performance of drug-eluting stent technology.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range with some predicting a 5 billion dollar market within the next 2 years. The actual direct cost increase associated with Taxus compared to a bare metal stent is significant. Each Taxus stent will likely cost between $2500 and $3000. This represents an increase of 200-300% over the per unit cost of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The Taxus Express stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Cardiology
Regulatory Status: Approved

BioHorizon Impact Score: 84/100 – High

CYPHER Sirolimus-eluting Stent

admin — Fri, 20 Feb 2004 20:49:04 +0000

On February 18, 2004, Cordis Corporation announced completion of patient enrollment in the first randomized head-to-head coronary stent trial comparing its new CYPHER sirolimus-eluting coronary stent with the Taxus Express (2) paclitaxel-eluting coronary stent. This trial is expressly designed to compare performance differences between the two drug-eluting stents, particularly in high-risk patient group subsets such as diabetics and patients with long lesions and small-diameter vessels. The CYPHER stent is currently the only FDA approved drug-eluting stent available for use in the United States. Boston Scientific’s Taxus paclitaxel-eluting stent has yet to receive approval from the FDA. Unlike traditional or ‘bare metal’ stents, the CYPHER stent is coated with a naturally occurring substance named sirolimus and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the sirolimus into the vessel wall to stop the growth of scar tissue, which causes restenosis. The pivotal Cordis-sponsored Sirius Clinical Trial involving 1,058 patients demonstrated as much as a 91% reduction in in-stent restenosis, and a 75% reduction in target lesion revascularization versus the control arm. Sirolimus is a cytostatic agent, meaning it stops cells from dividing without destroying them. It is an anti-rejection medication first used in kidney transplant patients.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. The CYPHER stent, approved for U.S. marketing in April 2003, has been used to treat approximately 500,000 patients in more than 80 countries worldwide. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range. The actual direct cost increase associated with CYPHER compared to a bare metal stent is significant. Each CYPHER stent costs in the $2500 to $3000 range. This represents an increase of 200-300% over the per unit costs of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The CYPHER stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.