FDA approves two spine devices

by emma 31. October 2011 12:09

Spinal USA S-Lok PC Posterior Cervical System

The FDA has approved Spinal USA’s two spinal treatment products, the VAULT Stand Alone ALIF System and the S-Lok PC Posterior Cervical System (pictured, right).

Rich Dickerson, Senior Vice President of Operations for Spinal USA, said that the two medical devices “provide our customers with a wider array of surgical options”.

The VAULT System (pictured, below) is designed for use with autogenous bone graft for intervertebral body fusion of the spine in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, aiming to “reduce surgical trauma and yield a net cost saving”, said Mr Dickerson.

He added that the S-Lok PC Posterior Cervical System offers “surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility”, indicated to promote fusion of the cervical and thoracic spine in mature patients in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and revision of previous cervical spine surgery and tumours.

Spinal USA VAULT Stand Alone Alif System DDD is characterised by back pain caused by the degeneration of the disc. Spondylolithesis is a condition in which a bone in the lower part of the spine slips out of place.

Cervical spine surgery is intended to restore nerve function, stop or prevent abnormal motion in the spine, and relieve pain, numbness, tingling and weakness.

Mississippi-based Spinal USA provides spine products for the treatment of serious medical conditions, aiming to reduce medical costs.

PEP acquires surgical device specialist

by emma 18. October 2011 10:19

MB medtech news

Precision Engineered Products (PEP) has acquired Boston Endo-Surgical Technologies (BE-ST), a specialist in the development of spinal and orthopaedic surgical instruments.

BE-ST provides a firm pipeline of technologies to strengthen PEP’s spinal surgery portfolio.

Alan Huffenus, CEO of PEP, said that the acquisition of BE-ST will continue the company’s “strategy of expanding our offering of highest technology medical devices that extend people’s lifespan and improve outcomes of surgical procedures”.

Massachusetts-based PEP is a manufacturer of surgical instruments including surgical stapling devices, endoscopic and laparoscopic devices and drug delivery systems.

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