What Is The Future Of Medtronic & The Spinal Fusion Market?

The recent controversy surrounding Medtronic Inc.’s Infuse bone graft is having some question what the future will hold for the company, and for the spinal fusion market.

First approved by the U.S. Food and Drug Administration (FDA) in 2002, Medtronic’s Infuse bone graft has been cleared for use in a type of spine surgery called anterior approach lumbar fusion, as well as two types of dental procedures. However, recent research has shown that Infuse, also known as recombinant human Bone Morphogenetic Protein-2 or BMP2, may increase the risk that patients will develop cancer and other serious side effects.

Concerns have also been raised about the Medtronic-funded clinical trials used to gain approval of Infuse, with some researchers charging that the studies downplayed serious complications associated with the bone growth protein.

Medtronic has also faced investigations launched by the U.S. Justice Department and the U.S. Senate Finance Committee over possible illegal promotion of Infuse for off-label uses, as well as a growing number of personal injury lawsuits filed by victims of alleged Infuse complications.

And, all of this controversy surrounding the medical device has caused the sales to continually and steadily decline, quarter after quarter, as doctors began limiting its use or abandoning it altogether.

In an effort to salvage the reputation of Infuse, Medtronic has commissioned Yale reviewers to conduct an independent review of the data related to Infuse. The review’s conclusions are eagerly awaited by Medtronic CEO Omar Ishrak who hopes that Infuse will be vindicated once and for all therebysilencing those who have raised questions about the safety of this blockbuster spinal fusion product.

But one research analyst who does not cover Medtronic believes that Infuse’s fortunes won’t rise even if Yale reviewers grant it a clean bill of health.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will (doctors) go back to it, I don’t think so,” said Caroline Corner, an analyst with investment bank MLV & Co.

So, what will happen with the future of the market?  The drop in the utilization rate of Infuse now leaves the door open for other companies trying to develop an alternative to Medtronic’s Infuse, Corner said.

According to a report from MedCityNews, while no product is currently available that could completely replace Infuse, there are a few that could come to be considered a next-best option.

These include Osteocel Plus sold by California firm NuVasive; Trinity Evolution, sold by Orthofix Biologics in Texas; and Vitoss sold by Pennsylvania firm Orthovita, now part of Stryker.

One product, called OsteoSponge, appears to be particularly promising, according to an analyst interviewed by MedCityNews. Made by Bacterin International, OsteoSponge performed well against Infuse in a small, head-to-head clinical trial. Not only did it perform as well as Infuse with none of the risks connected to the Medtronic product.  And, OsteoSponge costs about 1/3 less than it’s competitor. Caroline Corner, the analyst from MLV & Co., told MedCityNews that if OsteoSponge can do as well in a larger clinical trial, it could gain some of Infuse’s market share.



, , , ,

No comments yet.

Leave a Reply

GET HELP NOW!
  • This field is for validation purposes and should be left unchanged.
Latest Drug Injury News

Merck’s Falsification of Vaccine Data Exposed

Merk’s dirty little secret has been exposed. A pair of lawsuits, one filed by former employees of Merck and the other by doctors, alleged the company knew its mumps vaccine was less effective than the supposed 95 percent efficiency level. According to court documents the former virologists employed by Merck filed a whistleblower lawsuit four […]

Testosterone Therapy Linked To Heart-Attack, Stroke and Death

Millions of men have turned to testosterone therapy to treat symptoms of aging. However, they may not be aware that they are putting themselves at risk for heart attack or stroke. According to the latest study published in the journal PLOS ONE, researchers report that within 90 days of taking the hormone the risk of […]

What Is Doribax?

According to the FDA the antibacterial drug Doribax, that has been used to treat patients who develop pneumonia on ventilators, carries an increased risk of death and has a lower clinical cure rate by injection compared a similar drug known as Primaxin. What is Doribax? Doribax is an antibiotic that fights serious infections caused by […]

Is Using Tylenol or Ibuprofen During Pregnancy linked to ADHD?

What is a mother to do if she becomes ill during pregnancy?  The risks of consuming common drugs when pregnant are complex.  Although many doctors assure mothers that taking Tylenol is safe, a recent study by JAMA Pediatrics suggests otherwise.  The study found that mothers who used Tylenol for fever reduction while pregnant reported greater […]

Paxil Linked To Breast Cancer

City of Hope Cancer researchers indicate that a new test called the AroER Tri-Screen, desgined to look for drug side effects that could cause cancer, found a potential link between Paxil and breast cancer.  Paxil is a widely prescribed anti depressant. Research Researchers have found that Paxil has a weak estrogen effect that could increase […]

Latest Medical Device Injury News

Report Raises Concerns Over Heart Defibrillator Leads

The Food and Drug Administration (FDA) has just announced that they received a report that a St. Jude Durata cardiac defibrillator lead conductor became externalized; meaning the wire carrying electricity from the heart defibrillator to the heart was exposed through its insulation, a potentially dangerous and life-threatening defect.

HeartSine Class 1 Defibrillator Recall

HeartSine sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery.

FDA Medical Device Approval Based On Little Evidence

More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.

St. Jude Medical Gets FDA Warning

St. Jude Medical Inc. said it received a FDA warning about manufacturing and quality-control problems at its Sylmar, California, plant.

Hospira Still Facing Manufacturing And Regulatory Issues

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.