Product briefs: FDA okays PLC’s Heart Laser for TMR
Just over a year after its initial application to the FDA was rejected due to incomplete data, PLC Sys-tems (Franklin, Massachusetts) received U.S. market-ing approval Aug. 20 for its Heart Laser and transmy-ocardial revascularization. The approval covers use of the device on patients suffering from severe angina who have exhausted all other treatment options. The Heart Laser drills from 20 to 40 one-millimeter holes through the wall of the heart, creating channels for blood to flow into the heart muscle. William Dow, PLC president and CEO, said U.S. commercial sales of the system began within hours after FDA approval was received. Dow told BBI that he was “very elated” over receipt of the approval. “This has been an interesting journey,” said Dow, who joined PLC after last year’s advisory panel recom-mendation to reject the company’s initial application. Elsewhere in the product pipeline:
* Arterial Vascular Engineering (AVE; Santa Rosa, California) said that its INR (neurovascular or cerebral/brain) stent has received first implant as part of a clinical study under an investigational device exemption granted to the State University of New York at Buffalo. The stent is placed inside the patient’s intracranial carotid artery and across an aneurysm in order to divert blood flow away from the aneurysm and to initiate its spontaneous clotting or thrombosis. If complete thrombosis is not achieved, the aneurysm is filled with tiny platinum coils during a subsequent procedure, creating a buttress between the aneurysm wall and the normal carotid artery. The stent was developed from Arterial Vascular’s GFX coronary stent platform system.
* ArthroCare (Sunnyvale, California) has com-pleted a Phase I clinical trial demonstrating that its cosmetic surgery system removes “crow’s feet” wrin-kles. The company said the system causes less pain and more rapid healing compared with other laser techniques. The system uses radiofrequency energy to remove tissue and is significantly cooler than other treatments. The company will next conduct a 90-day Phase II clinical study using the system in skin resur-facing for wrinkle removal.
* Autonomous Technologies (Orlando, Florida) has received FDA approval of the company’s premarket approval application for its LadarVision Excimer Laser System, with final approval dependent on the compa-ny’s manufacturing systems complying with FDA rules. The approval is for up to minus 10 diopters of sphere and minus 4 diopters of cylinder. The range of sphere is broader than the minus 8 diopters recommended earlier by the agency’s Ophthalmic Devices Panel and is based on additional data from Autonomous.
* BioLase Technology (San Clemente, California) has received a U.S. patent for a new medical device and technology, which simultaneously applies med-ications or other substances during a surgical proce-dure. The Fluid Conditioning Technology device attaches to an existing medical or dental instrument – including virtually all lasers – to supplement tradi-tional surgically applied fluids such as water or air with medications, anesthetics, flavors or scents, and eliminates the need for separate, more cumbersome tools. The patent specifically covers the device’s use with surgical laser systems, hydrokinetic devices, electrocauterizers and other medical and dental tools.
* Bio-Vascular (St. Paul, Minnesota) has received approval to use the CE Mark for its Flo-Rester and Bio-Vascular Probe surgical products. The Flo-Rester is a vessel occluder which interrupts blood flow in arteries and holds them open during surgery to facil-itate vessel suturing. It is made in both reusable and disposable varieties. The Bio-Vascular Probe is a flex-ible shaft with bulbous tips on either end, used by surgeons to locate blockages in arteries and to deter-mine the blood flow characteristics of arteries.
* Cardiac Pathways (Sunnyvale, California) has received the CE Mark for its Trio/Ensemble diagnos-tic catheters, allowing sale in Southern Europe. The catheters are used for electrophysiological diagnostic mapping of supraventricular tachycardia, a congeni-tal, rapid heart rhythm originating above the ventri-cles. The Trio/Ensemble catheters allow the electro-physiologist to place three catheters through a single site rather than having to use separate introduction sites and allowing assessment of electrical conduction between the atria and the ventricle. The catheters are the company’s third product line to receive the CE Mark this year.
* Cardio Medical Solutions (CMS; Fountain Val-ley, California) has received FDA 510(k) clearance for the Baladi Inverter, a device inserted in the aortic inci-sion, then inverting to form a bowl, enabling a blood-free workspace for aortic grafting. The device can be used in open-chest surgery under cardiac arrest or during beating-heart bypass surgery. The design is intended to decrease compressing forces from side-biting clamps to reduce complications from the gen-eration of particulates during bypass procedures. The device is named for its co-inventor, Naom Baladi, MD. CMS said it also intends to file for its second product, the Balloon Tipped Cannula, later this year
* Document Control Systems (Salt Lake City, Utah) has released its MasterControl FDA Edition software, designed to help manufacturers to meet the electronic signature and document security require-ments of the FDA’s Good Manufacturing Practices cer-tification. The product features dual signature path for ultra-secure electronic document approval, 32-bit pass-word encryption to ensure tight password security, password expiration, intruder lock-out and account lockout functions. MasterControl FDA Edition is a Windows-based client/server application combining time-based routing capabilities with a secure docu-ment vault system in a scalable, open systems architec-ture. It includes field level change tracking and change rationale tracking which record the date, time, changes, and rationale for the changes made to documents.
* Escalon Medical (Wayne, Pennsylvania) has received the European CE mark for its disposable delivery systems, which include a viscous fluid injec-tion pack and universal gas-mixing kits for intraocu-lar gas injection. Escalon develops and markets oph-thalmic medical devices and pharmaceuticals.
* Gish Biomedical (Irvine, California) said a study of its Vision Oxygenator has indicated that the system provides the highest level of oxygen provided by any oxygenator system. The Vision Oxygenator functions as a lung during cardiovascular surgery, enabling gas exchange of oxygen and carbon dioxide while the patient’s blood temperature is regulated. The system was launched in January.
* International Isotopes (Denton, Texas) has re-ceived FDA 510(k) approval to market its I-125 brachytherapy seeds, used as primary treatment for prostate cancer or unresectable tumors or secondary treatment for residual disease. Implanted into the prostate under ultrasound guidance, the seeds feature manufacturing technology which doubles encapsula-tion for patient safety and a desired dose distribution of radioactive material. They will be marketed by Imagyn Medical Technologies (Laguna Beach, California) under the brand name IsoStar, beginning in 4Q98.
* Interpore International (Irvine, California) has received FDA 510(k) approval to market its new bone plate system for treating internal fixation of pelvic frac-tures. The system enables screw holes to be spaced intraoperatively and allows bone graft material to be placed after the plate and screws are implanted. The company expects to begin market release of the system early next year.
* LaserSight (Orlando, Florida) has received FDA premarket application approval for its Kremer Excimer Laser to perform Laser In-Situ Keratomileu-sis, or LASIK, surgery, the only laser approved for this procedure. The approval allows a procedure using a 6 mm ablation zone to treat myopia ranging from minus 1.0 to minus 15 diopters, with or without astig-matism ranging from 0.0 to 5.0 diopters. This is the only laser approved by the FDA to treat high myopia up to minus 15 diopters. LaserSight said it will seek the supplemental manufacturing approval required to commercialize the system.
* Medical Carbon Research Institute (Austin, Texas) has received the CE Mark for its On-X Heart Valve prosthesis. The On-X Heart Valve is a bileaflet mechanical valve made from On-X carbon, an unal-loyed pyrolytic carbon. It features a shaped and lengthened orifice that reduces pressure losses, tur-bulence and shear stresses, with flow area maxi-mized by supra-annular positioning and by the increased On-X carbon strength to minimize wall thickness and stiffening ring bulk. The company said that clinical hemodynamic results using the valve showed significant improvements over other bileaflet designs.
* Medtronic (Minneapolis, Minnesota) has released its Jewel AF implantable arrhythmia management device in Europe and other international markets. Described as an “all-in-one” device, the Jewel AF fea-tures the company’s advanced defibrillator capabili-ties for treating the lower chamber of the heart as well as the capabilities of modern dual-chamber pacemak-ers that treat slow heartbeats in both upper and lower chambers. It also offers a range of new capabilities for detection and treatment of arrhythmias in the atrium. Medtronic describes the device as the first designed to deliver staged, or tiered, atrial therapies and pac-ing, and, at 55 cc and 93 grams weight, is the smallest and lightest dual-chamber defibrillator made.
* Meridian Medical Technologies (Columbia, Maryland) has introduced its Intraject product, a pre-filled, disposable, needle-free injector that can be used for drug self-administration by patients. About half the size of a fountain pen, the device is disposable, easy to use, low in cost and virtually pain-free. Acti-vated by compressed nitrogen, a precise dosage of medication is injected within 50 milliseconds. It elim-inates the possibility of needlestick accidents and potential infection.
* Merit Medical Systems (South Jordan, Utah) has received FDA clearance to market its patent-pending Squirt fluid dispensing system for delivery of throm-bolytic agents used in conjunction with the Fountain Infusion System and catheter. The combination of instruments is used to treat peripheral arterial occlu-sions, hemodialysis graft occlusions and deep vein thrombosis. The Squirt features adjustable pulse vol-ume providing precise dosages over long periods of time without causing hand fatigue.
* Photoelectron (Lexington, Massachusetts) has received FDA 510(k) clearance for its Photon Radio-surgery System 400, an X-ray tumor therapy delivery system. The PRS400 is an advanced, microprocessor-controlled version of the company’s PRS, with improved operating features. Approved by the FDA last year, the PRS has been used in clinical tests in the U.S., England, Germany, Italy and Japan to treat both metastatic and primary brain cancers. The system’s non-radioactive source delivers a controlled high dose of X-rays in a single treatment, with the radia-tion injected directly into the tumor through a mini-mally invasive probe tailored to the tumor site. Fur-ther applications under development include intraop-erative clinical breast tumor trials and the irradiation of skin cancers.
* Somnus Medical Technologies (Sunnyvale, California) has filed for FDA approval to market its Somnoplasty System to treat obstructive sleep apnea, an additional application for the system, which was previously cleared to treat habitual snoring and chronic nasal obstruction.
* The FDA Ophthalmic Advisory Panel has rec-ommended approval of the Toric intraocular lens produced by STAAR Surgical (Monrovia, Califor-nia). The product is an intraocular synthetic replacement lens for patients with pre-existing astigmatism. The company’s principal product line includes foldable intraocular lenses that are used as replacements for the natural lens in cataract proce-dures.
* The first European implants of the TheraSeed radioactive device for the treatment of localized prostate cancer produced by Theragenics (Norcross, Georgia) have taken place in Milan, Italy. Initial implants of the rice-sized palladium-103 radioactive device were conducted by Italian physicians who attended the first brachytherapy training seminar conducted by Theragenics’ marketing partner, Indi-go Medical (Cincinnati, Ohio). TheraSeed has received the CE Mark, allowing its European market-ing.
* Thoratec Laboratories (Pleasanton, California) has received FDA clearance for use of its VAD (ven-tricular assist device) system for post-cardiotomy recovery from open-heart surgery. The expanded use is in addition to the VAD system’s previously approved use as a bridge to transplant in patients awaiting a new heart. The VAD system also is being sold in Europe, Canada and other countries as a bridge to transplant.
* Urologix (Minneapolis, Minnesota) has re-ceived expanded FDA approval for its Targis system to include treating of an obstructed urethra caused by benign prostatic hyperplasia or enlarged prostate dis-ease. The agency approved the Targis system in August 1997 for treating benign prostatic hyperplasia symptoms, such as frequent urination, hesitancy or straining when urinating.
* Uromed (Needham, Massachusetts) has sub-mitted a premarket notification application to the FDA to market its brachytherapy radioactive seeds for treatment of prostate cancer. A developer of uro-logical, gynecological and prostate products, Uromed said it is meeting its timeline for entrance into the brachytherapy market by early 1999.
* Uroplasty BV, a Netherlands-based division of Uroplasty (Minneapolis, Minnesota), has received approval from the Canadian Medical Devices Bureau to market Macroplastique, an injectable soft tissue bulking agent used to treat male and female stress uri-nary incontinence and vesicoureteral reflux. The product is not yet available in the U.S.
* Vital Images (Minneapolis, Minnesota) has released Vitrea 1.1, an enhanced version of its 3-D medical visualization software introduced last fall. Vitrea provides visualization of diagnostic images from computed tomography and magnetic reso-nance scanners in 2-D and 3-D, plus navigation – or “fly-through” – 3-D interactive images for clini-cal radiology and surgical planning. Features include semi-automatic segmentation, automatic navigation, and faster, automatic higher-resolu-tion.
* Westaim Biomedical (Fort Saskatchewan, Canada), a division of the Westaim Corp., said that its Acticoat Antimicrobial Barrier Dressing to treat burn wounds has received CE mark certification for mar-keting in Europe. The dressing features a system for the continuous release of bactericidal silver which provides protection against infection and reduces the number of dressing changes required. The rapid antimicrobial action is effective against a broad range of bacteria, including resistant strains and non-adher-ent properties of the dressings ease removal and reduce pain. Other potential uses include chronic wound care for diabetic and pressure ulcers, urologi-cal and central venous catheters and orthopedic and other implants.
* World Medical Manufacturing (Sunrise, Florida) has received FDA Investigational device Exemption to begin human clinical studies of its Talent Endoluminal Stent Graft System for treating aneurysms of the thoracic aorta. The company has also received permission to expand the Phase II IDE study of the Talent device for treating abdom-inal aortic aneurysms to an additional 150 patients with low to moderate surgical risk status. Foreign human clinical evaluation of the Talent AAA device began in 1995, and CE Mark status was granted for both the AAA and thoracic models ear-lier this year.
* Zoll Medical (Burlington, Massachusetts) has launched its new line of MSeries emergency resusci-tation units, combining monitoring, defibrillation and Zoll’s patented external pacing technology. The instrument weighs 11 pounds, approximately one-third the size and one-half the weight of most other full-featured defibrillators. It features a high-contrast display of cardiac rhythm and uses a platform allow-ing for the addition of future physiological monitoring capabilities.
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